Brief team/department description:

As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies.  The person will play crucial role in managing lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.

Principle Responsibilities:

• Provide regulatory assistance with due diligence requests to support new business development activities.
• Support interaction with FDA and other regulatory agencies for assigned commercial products.
• Assist in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post marketing supplements for assigned products.
• Manage the timelines associated with regulatory submissions such as post-marketing periodic reports.
• Manage archival of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms.
• Provide regulatory guidance on requirements for post-approval changes, as required, for assigned products.
• Review and provide regulatory assessments for change control documentation.
• Provide regulatory support to regulatory leadership meetings and presentations.
• Keep abreast of current regulations and regulatory guidance, assessing impact to assigned products and internal processes.
• Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
• Other duties as assigned.

Qualifications and Education Requirements

• Minimum of Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
• Minimum of 3 years in the pharmaceutical industry with at least 1 of those years in regulatory affairs.
• Combination of education and applicable job experience may be considered.
• Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.​
• Ability to work independently with minimal supervision in a fast-paced deadline driven environment​.
• Keen attention to detail.
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met​.
• Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.

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Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities.  The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

 Principle Responsibilities:

• Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
• Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
• Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
• Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
• Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
• Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
• Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports

CORE Responsibilities

• Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
• Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
• Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
• Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
• Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
• Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
• Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
• Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
• Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements

• 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
• Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
• Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
• Bachelor’s degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

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If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the Global Head of Regulatory Affairs your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.

As the Global Head of Regulatory Affairs working on the Global Regulatory Affairs team you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.

Principle Responsibilities:

• Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. Ensures compliance for global regulatory requirements.
• Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors.
• Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor.
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
• Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.
• Oversees all submissions.
• Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary.
• Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Qualifications and Education Requirements:

• MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
• Proven success in regulatory submissions.
• FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines.
• Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
• Experience with investigational drugs, including late stage development, and marketed products
• CRO management experience preferred.
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
• Must be a strong leader that creates a vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
• Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Strategic thinker, planner, and implementer with excellent organizational skills.
• Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents.
• Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes.
• Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and within global teams.
• Independent thought, negotiation skills, integrity, and adaptability.
• Ability to work on own and in virtual setting.
• MS Office skills with excellent use of excel, PowerPoint and MS Project required.
• Recent experience with a smaller entrepreneurial environment is a definite asset.
• Fluent in English (written and oral).

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If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the Global Head of Regulatory Affairs your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.

As the Global Head of Regulatory Affairs working on the Global Regulatory Affairs team you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.

Principle Responsibilities:

• Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. Ensures compliance for global regulatory requirements.
• Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors.
• Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor.
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
• Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.
• Oversees all submissions.
• Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary.
• Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Qualifications and Education Requirements:

• MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
• Proven success in regulatory submissions.
• FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines.
• Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
• Experience with investigational drugs, including late stage development, and marketed products
• CRO management experience preferred.
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
• Must be a strong leader that creates a vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
• Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Strategic thinker, planner, and implementer with excellent organizational skills.
• Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents.
• Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes.
• Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and within global teams.
• Independent thought, negotiation skills, integrity, and adaptability.
• Ability to work on own and in virtual setting.
• MS Office skills with excellent use of excel, PowerPoint and MS Project required.
• Recent experience with a smaller entrepreneurial environment is a definite asset.
• Fluent in English (written and oral).

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About the Role

Role Summary

The Director, US Controller provides senior‑level oversight of US accounting, financial reporting, and Gross‑to‑Net (GTN) accounting, delivered through a Global Capability Center (GCC). This role is accountable for the quality, accuracy, and GAAP compliance of the US close, while day‑to‑day execution is performed by the GCC.

The Director serves as the primary US accounting authority, owning accounting policy, technical judgment, review, and audit interaction. The role partners closely with Commercial, FP&A, Contracting, and External Auditors to ensure reliable, decision‑ready financials in a GTN‑intensive commercial environment.

Key Responsibilities

US Close & Financial Reporting Oversight

• Provide overall governance and oversight of the US monthly, quarterly, and annual close executed by the GCC.
• Own the close calendar, review framework, and escalation process.
• Review and approve all material journal entries, estimates, and balance sheet reconciliations.
• Ensure timely delivery of accurate US GAAP financial statements and management reporting.
• Serve as final accounting approver prior to submission to senior leadership and auditors.

Gross‑to‑Net Accounting Leadership

• Own GTN accounting policy, methodology, and estimation framework.
• Review and challenge GTN reserve calculations prepared by the GCC, including:
• Chargebacks
• Commercial and government rebates
• Returns and return reserves
• Admin/service fees, distribution fees, prompt pay, and other deductions
• Apply accounting judgment to assumptions, lag analysis, utilization trends, and true‑ups.
• Partner with Commercial, Managed Markets, and Contracting teams to ensure GTN accounting reflects contractual reality.
• Explain GTN movements, risks, and volatility drivers to FP&A and senior finance leadership.

GCC Governance & Quality Control

• Act as the primary onshore accounting oversight lead for the GCC‑supported US close.
• Define clear roles, review standards, and documentation expectations.
• Conduct structured reviews of GCC output to ensure consistency, accuracy, and GAAP compliance.
• Identify quality or control issues and work with GCC leadership to remediate.
• Escalate and resolve complex accounting matters requiring onshore judgment.

Controls, Audit & Policy

• Own US accounting policies, technical memos, and key accounting judgments.
• Ensure GCC‑executed processes are well‑documented, controlled, and audit‑ready.
• Serve as the primary US accounting contact for external auditors.
• Lead audit planning, walkthroughs, technical discussions, and issue resolution.

Required Qualifications

• Bachelor’s degree in Accounting or Finance; CPA.
• 12+ years of progressive accounting experience, including Controller or Director‑level roles.
• Deep Gross‑to‑Net accounting experience, ideally in pharma or life sciences.
• Experience operating within a GCC or offshore‑supported accounting model.
• Strong US GAAP knowledge with demonstrated judgment in revenue, estimates, and reserves.
• Proven strength in review, governance, and stakeholder management rather than transaction execution.

Leadership Profile

• Senior accounting reviewer and technical authority
• Comfortable challenging assumptions and outputs
• Clear communicator with executives and auditors
• Strong governance and quality mindset
• Effective influencer across onshore and offshore teams

What Success Looks Like

• Consistent, high‑quality US close delivered through the GCC
• Defensible, explainable GTN reserves with minimal surprises
• Smooth audits with strong documentation and limited rework
• High trust from Commercial, FP&A, and Finance leadership

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Brief team/department description:

The Director of Franchise Portfolio Management at Azurity plays a crucial role in strategy development, management, and execution for the franchise product portfolio, supporting the VP of Franchise Portfolio Management.

Principle Responsibilities:

• Gain a strong expertise in the therapy areas overseen by the franchise through targeted research, competitive intelligence, engagement with market and customer insights, and attendance at key conferences.
• Contribute to franchise-level strategic plans, including mature asset management and revenue optimization.
• Drive brand strategy development and execution through each Product Lifecycle Management (PLM) stage, ensuring readiness for launch.
• Manage brand plans, pricing strategies, forecasts and forecast assumptions, target product profiles (TPPs), and P&Ls over the life of products/brands managed by the franchise. Guide launch archetype development and post-launch enhancements, including line extensions and phase-outs.
• Continuously gather and analyze customer insights to refine product and commercial strategies.
• Oversee product enhancements and line extensions after market introduction, and plan for phase-outs and support withdrawal as products reach end-of-life.
• Support Product Lifecycle Management (PLM) process through all stages under the guidance of VP Franchise Portfolio Management, and coordinate with relevant cross-functional teams to meet stage-gate criteria and timelines and recommend product discontinuations when needed.
• Assist in preparing reports, presentations, and recommendations for portfolio reviews and strategic planning sessions.
• Work with the corporate development team to identify, evaluate, and integrate external assets that enhance the internal portfolio and strengthen product offerings.

Qualifications and Education Requirements

• PharmD or PhD or bachelor’s or master’s degree in a relevant field (e.g., Life Sciences, Business Administration) preferred.
• 5+ years of relevant experience with an advanced degree; 10+ years with a bachelor’s degree
• Experience in pipeline or in-line marketing or new products commercialization
• Familiarity with therapeutic areas and pharmaceutical drug development and commercialization.
• Experience conducting primary and secondary market research and developing, discussion guides, target product profiles (TPPs), forecast assumptions for new product ideas.
• Experience in sales forecasting and financial modeling.
• Knowledge of pharmaceutical product lifecycle management and commercialization processes.
• Detail-oriented with strong organizational skills, capable of managing multiple tasks and priorities.

CRITICAL LEADERSHIP CAPABILITIES

• Provides effective support and coordination within cross-functional teams.
• Make informed decisions and manage resources effectively within the scope of the role.
• Communicate effectively with both technical and commercial stakeholders, supporting alignment and execution of strategic goals.

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Brief team/department description:

The Director of Franchise Portfolio Management at Azurity plays a crucial role in strategy development, management, and execution for the franchise product portfolio, supporting the VP of Franchise Portfolio Management.

Principle Responsibilities:

• Gain a strong expertise in the therapy areas overseen by the franchise through targeted research, competitive intelligence, engagement with market and customer insights, and attendance at key conferences.
• Contribute to franchise-level strategic plans, including mature asset management and revenue optimization.
• Drive brand strategy development and execution through each Product Lifecycle Management (PLM) stage, ensuring readiness for launch.
• Manage brand plans, pricing strategies, forecasts and forecast assumptions, target product profiles (TPPs), and P&Ls over the life of products/brands managed by the franchise. Guide launch archetype development and post-launch enhancements, including line extensions and phase-outs.
• Continuously gather and analyze customer insights to refine product and commercial strategies.
• Oversee product enhancements and line extensions after market introduction, and plan for phase-outs and support withdrawal as products reach end-of-life.
• Support Product Lifecycle Management (PLM) process through all stages under the guidance of VP Franchise Portfolio Management, and coordinate with relevant cross-functional teams to meet stage-gate criteria and timelines and recommend product discontinuations when needed.
• Assist in preparing reports, presentations, and recommendations for portfolio reviews and strategic planning sessions.
• Work with the corporate development team to identify, evaluate, and integrate external assets that enhance the internal portfolio and strengthen product offerings.

Qualifications and Education Requirements

• PharmD or PhD or bachelor’s or master’s degree in a relevant field (e.g., Life Sciences, Business Administration) preferred.
• 5+ years of relevant experience with an advanced degree; 10+ years with a bachelor’s degree
• Experience in pipeline or in-line marketing or new products commercialization
• Familiarity with therapeutic areas and pharmaceutical drug development and commercialization.
• Experience conducting primary and secondary market research and developing, discussion guides, target product profiles (TPPs), forecast assumptions for new product ideas.
• Experience in sales forecasting and financial modeling.
• Knowledge of pharmaceutical product lifecycle management and commercialization processes.
• Detail-oriented with strong organizational skills, capable of managing multiple tasks and priorities.

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Franchises Supported: CORE and ARGO

Level: Director

Role Summary

The Director, Franchise Program Management – CORE & ARGO is a franchise‑anchored leadership role responsible for stewarding Azurity’s Product Lifecycle Management (PLM) process and Management System across the CORE and ARGO franchises. The role ensures disciplined execution, cross‑functional accountability, and effective governance from early ideation through launch, lifecycle management, and value realization.

This role operates as a trusted integrator and enablement leader—partnering closely with Franchise Portfolio Management (FPM), Medical, Clinical, Regulatory, Commercial, CMC, Finance, and Operations leaders to ensure that franchise priorities are translated into clear plans, aligned execution, and decision‑ready governance. The Director does not own product strategy or functional execution, but is accountable for ensuring that the PLM system works predictably, transparently, and at enterprise standard.

Key Responsibilities

Product Lifecycle Management (PLM) Stewardship

• Serve as the primary steward of the PLM process for CORE and ARGO assets across all lifecycle stages (cradle to grave)
• Ensure consistent application of PLM stages, stage‑gate criteria, and governance expectations
• Maintain clear visibility into asset status, readiness, risks, and upcoming decision points
• Identify gaps or deviations from PLM expectations and drive corrective action

Accountability & Execution Enablement

• Establish and maintain clear cross‑functional ownership, milestones, and deliverables for franchise assets
• Track progress, risks, dependencies, and interlocks across asset teams
• Hold peers accountable to commitments through disciplined follow‑up and escalation, without owning functional execution
• Surface issues early and frame options to support timely leadership decisions

Cross‑Functional Collaboration & Integration

• Act as the connective tissue across Medical, Clinical, Regulatory, Commercial, CMC, Supply Chain, Finance, and Operations
• Facilitate effective cross‑functional discussions that drive alignment and resolve ambiguity
• Ensure functional inputs are integrated into a cohesive franchise‑level execution view
• Promote enterprise‑first thinking over functional optimization

Governance & Decision Readiness

• Prepare asset teams for PLM stage‑gates, franchise governance, and executive reviews
• Ensure materials are complete, aligned, and decision‑ready
• Confirm that recommendations clearly articulate risks, trade‑offs, and implications
• Determine readiness to advance assets through governance forums

Management System & A3 Leadership

• Act as a visible advocate and steward of Azurity’s Management System within CORE and ARGO
• Ensure appropriate use of A3s to manage priorities, risks, and complex cross‑functional problems
• Coach asset teams on structured problem‑solving, transparency, and disciplined execution
• Drive continuous improvement in PLM and franchise ways of working

Business Development & Integration Support

• Partner with Business Development and FPM to support diligence activities for CORE and ARGO assets
• Coordinate cross‑functional inputs during diligence using Management System principles
• Support integration planning and transition of new assets into the PLM framework

Qualifications

• Demonstrated success leading cross‑functional program or portfolio management in pharmaceutical or biotechnology environments
• Strong understanding of product lifecycle management, stage‑gate governance, and launch readiness
• Proven ability to lead through influence and hold peers accountable without direct authority
• Experience operating in matrixed organizations with multiple stakeholders and priorities
• Excellent executive communication, facilitation, and issue‑framing skills
• Comfort navigating ambiguity, trade‑offs, and complex decision environments

Success Profile

The successful candidate is recognized as a calm, credible franchise integrator who brings clarity and discipline to complex work. They enable leaders to make timely, well‑informed decisions, ensure that the PLM system is trusted and predictable, and create an environment where cross‑functional teams collaborate effectively and execute with accountability.

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Brief team/department description:

As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. This person will play a critical role by determining that clinical strategies meet Health Authority regulatory requirements for investigational and approved marketing applications, as well as providing clinical strategic support for due diligence activities.  The Regulatory Affairs Director- Clinical Strategy will report to the Senior Director, Head of Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Franchise Managers, Clinical Development, Medical Affairs, and Product Development.

 Principle Responsibilities:

• Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements
• Provide critical evaluation and review of clinical documents to support successful execution of regulatory objectives; proactively identify potential risks and develop implement mitigation strategies
• Interact with and support the Azurity Clinical Development and Medial Affairs teams to review clinical protocols and other documents; provide regulatory clinical strategic input
• Preparation and presentation of research data and findings on clinical/regulatory strategy to Azurity Executive and Senior Leadership to gain alignment on proposed regulatory strategy
• Demonstrate knowledge and understanding of integrated data from clinical trials including but not limited to efficacy, safety, pharmacovigilance, and clinical pharmacokinetics
• Participate/lead FDA and Health Authority interactions regarding clinical regulatory aspects, including formal meetings
• Mentor, develop and act as a trusted advisor to coach members of the regulatory team regarding clinical strategy and writing; this position may or may not have direct reports

CORE Responsibilities

• Authoring, preparation and/or review of relevant clinical sections of regulatory applications such as INDs, NDAs, BLAs, including ISS and ISE, initial pediatric study plans, waivers, clinical and non-clinical sections
• Assessment of regulatory and critical clinical approval factors including but not limited to PK, PREA and other post-marketing safety studies
• Evaluation and determination of regulatory pathways within relevant therapeutic areas to provide insight into potential development opportunities to support and build the Azurity R&D pipeline
• Evaluation and analysis of available literature for the development of bridging strategies required to support 505(b)2)NDA submissions
• Authoring, preparation and/or review of sections of various FDA communications including, but not limited to Information Requests, Priority Review and Orphan Drug Designation requests
• Preparation and/or review of Agency meeting documents including meeting requests and briefing documents; lead FDA meetings/interactions regarding regulatory clinical discussions
• Authoring, preparation and/or review of clinical and nonclinical sections of drug product labeling
• Represent Regulatory Affairs at cross-functional team interactions to provide clinical strategic input
• Provide strategic clinical regulatory support for due diligence projects across various therapeutic areas and dosage strengths

Qualifications and Education Requirements

• 10+ years of pharmaceutical industry experience within Regulatory Affairs, strong scientific and regulatory background
• Minimum of 5 years of experience in development of regulatory clinical strategy and clinical writing to support marketing applications including INDs, NDAs, BLAs
• Experience leading teams, coaching, and fostering a culture of efficiency and teamwork
• Ability to adapt to rapidly changing environments and circumstances, requiring a sense of urgency while ensuring that all cGMP and regulatory requirements are met
• Strong communication skills (written and verbal) demonstrated ability to express complex information clearly and concisely
• Bachelor’s degree in a scientific discipline or other closely related discipline is required; advanced degree preferred (MS, PharmD, PhD)

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Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

About This Role

Axsome Therapeutics is currently searching for a field based Long-Term Care (LTC) Specialty Account Manager (SAM) to drive LTC commercial activities for an assigned geography by executing marketing strategies to ensure a successful launch and make a meaningful difference through the execution of commercial activities.

SAMs will be responsible for product performance at a territory level and expected to be a disease state expert, product champion and an account specialist. The SAM will provide account management support and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace.

Job Responsibilities and Duties include, but are not limited to, the following:

• Drive product adoption in LTC facilities
• Proficient in both virtual and live customer engagements
• Effectively call on LTC Care teams, building meaningful relationships across the entire LTC ecosystem: Psychiatrists, Neurologists, nurse practitioners, Physician assistants, Nurses and LTC staff, Closed-door pharmacies, clinical pharmacists, case managers and care coordinators.
• Develop a comprehensive and effective territory business plan inclusive of account plans for targeted LTC facilities aimed at achieving and exceeding quarterly & annual goals established by commercial leadership
• Promote within our approved labeling in a comprehensive, fair, and ethical manner that is consistent with industry specific and corporate legal and regulatory guidelines
• Develop strong customer relationships by better understanding the customer’s needs
• Serve as a resource/consultant to customers and staff regarding payer policies and processes (i.e., eligibility and benefit verification, prior-authorization, and appeals/denials)
• Navigate Market Access and Reimbursement. LTC SAMs must understand: payer requirements, pharmacy fulfillment processes, patient access programs, reimbursement tools such as cover my meds
• Maximize use of marketing resources to maintain and develop customer relationships for the purpose of growing the customers’ confidence to prescribe Axsome medications for appropriate patients
• Communicate territory activity in an accurate and timely manner as directed by management
• Provide feedback to sales and commercial leadership, colleagues, marketing, and other internal departments about changing environment and results
• Successfully complete all training classes in a timely manner
• Complete administrative duties in an accurate and timely fashion
• Manage efforts within assigned promotional budget
• Effectively collaborate across all corporate functions
• Attend medical congresses and society meetings as needed
• Ensure timely access for patients through patient services and savings programs
• Overnight travel as indicated by the needs of the business
• Additional responsibilities as assigned

Qualifications / Requirements 

• Bachelor’s degree from an accredited college or university 
• Minimum of 5 years of pharmaceutical/biotech sales experience, including 2+ years in LTC or account-based selling environments
• Demonstrated experience delivering outstanding results, including Top 10% or Elite/President’s Club performance
• Launch experience strongly preferred 
• Must live within the geography of the assigned territory
• Experience collaborating with cross-functional teams, utilizing differential resources to achieve business goals 
• Proven ability to successfully manage multiple tasks concurrently under accelerated timelines in a dynamic environment 
• Ability to thrive with ambiguity and business environments with high expectations
• Patient support services experience a plus 
• Strong digital marketing aptitude 
• Strong interpersonal, presentation, and communication skills 
• Frequent driving, including extended periods of time behind the wheel
• Prolonged sitting and standing as part of daily job functions
• Ability to lift and carry up to 30lbs regularly
• Overhead reaching required to close and secure liftgates or similar equipment

Salary & Benefits

The anticipated salary range for this role is $100,000 - $150,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.

Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Senior Consulting Director, Commercial Growth

Triumvirate Environmental is one of the largest integrated environmental services firms in North America, serving the life sciences, healthcare, higher education, and advanced manufacturing sectors. Our model combines on-site embedded personnel, project-based consulting, field services, and waste management into a single platform that delivers comprehensive solutions no pure-play competitor can replicate. With more than 500 embedded professionals working inside client facilities across the country, we maintain deep, enduring relationships with many of the most recognized names in pharmaceutical manufacturing, biotechnology, and medical devices. We are in a significant growth phase, scaling our consulting and professional services division substantially over the next several years.

What sets Triumvirate apart is that we do not just manage waste. We transform it. Our Plastics4Purpose program, built through organic investment and acquisition over more than a decade, converts tens of millions of pounds of regulated medical and laboratory plastics into commercial products every year. Combined with our embedded personnel who drive daily waste reduction and segregation improvement inside client facilities, and our consulting team who designs the multi-year circularity programs that close the gap between published targets and operational reality, we deliver the kind of self-funding projects that CFOs actively want in their capital plans.

About the Role

The Senior Director of Commercial Consulting Enablement is a senior commercial role that bridges our highly trained field sales organization and our consulting delivery teams. Approximately 70% of your time will be spent directly pursuing and closing complex, multi-service consulting engagements alongside field sellers. The remaining 30% will focus on enabling others: building playbooks, coaching sellers on discovery and qualification, developing pricing frameworks, and creating the tools and processes that make cross-selling consulting services systematic rather than opportunistic.

What makes this role distinctive is the commercial infrastructure you will have behind you. Our embedded sales organization has built robust relationships and track records with some of the most exciting companies in pharma and life sciences, and they are skilled at opening doors and growing relationships that traditional consulting firms spend years trying to access and build. Your job is to convert that access into consulting engagements and to equip sellers with the confidence, tools, and frameworks to bring consulting into every conversation.

The ideal candidate brings a blend of management consulting rigor and life sciences domain expertise. We value backgrounds in operational excellence, Lean and Six Sigma, manufacturing process optimization, regulatory compliance, and circularity program development as highly as traditional EHS consulting experience. If you have spent your career helping life sciences organizations solve complex operational problems or designing waste reduction and material recovery programs that deliver measurable financial returns, and have the commercial instincts to turn that expertise into a scalable business, this role was designed for you.

This position reports to our Head of Consulting. This role offers a hybrid work model and can be based anywhere on the East Coast between Boston, MA and Raleigh, NC.

Essential Responsibilities

• Personally pursue and close complex, multi-service consulting engagements in partnership with field sellers, demonstrating the collaborative selling model and building the playbook for others to follow.
• Design and implement cross-sell playbooks, discovery frameworks, and qualification tools that enable field sellers to identify and advance consulting opportunities within existing accounts.
• Coach and train field sales professionals on consulting value propositions, pricing structures, and client-facing positioning across EHS compliance, operational excellence, industrial hygiene, and circularity service lines, including how to frame waste reduction and material recovery programs as self-funding initiatives with quantified ROI.
• Develop and maintain a pricing governance framework that balances consulting margins with total account value, ensuring pricing decisions reflect the economics of the full client relationship across all service lines.
• Partner with regional sales leaders and account managers to build account-specific cross-sell strategies for the firm's largest life sciences, healthcare, and advanced manufacturing clients.
• Manage the pipeline tracking and reporting system for consulting opportunities, providing weekly visibility to senior leadership on pipeline health, conversion rates, and revenue forecasts.
• Design and deliver sales enablement content including competitive positioning materials, ROI calculators, case studies, and proposal templates.
• Collaborate with embedded services leadership to create a systematic process for identifying consulting triggers from the 500+ on-site personnel working inside client facilities, including waste segregation improvement opportunities, circularity program gaps, and operational efficiency signals.
• Contribute to thought leadership, conference presentations, and marketing content that supports the firm's positioning in the life sciences consulting market.

Required Qualifications

• 10+ years of progressive experience in life sciences consulting, EHS consulting, operational excellence, or a related professional services discipline, with at least 5 years in senior commercial, sales enablement, or business development role.
• Demonstrated track record of enabling sales teams to cross-sell or upsell consulting services into existing client relationships, with measurable revenue impact.
• Experience building commercial infrastructure: playbooks, pricing frameworks, pipeline systems, and training programs.
• Strong understanding of life sciences, pharmaceutical manufacturing, or healthcare client environments and the regulatory and operational landscape that governs them.
• Personal business development track record, with experience closing multi-site or enterprise-level consulting engagements.
• Excellent communication and presentation skills, with the ability to coach and influence experienced sales professionals.
• Willingness to travel 25%+, primarily to client sites and regional offices.
• Must be eligible to work in the United States without future sponsorship.

Preferred Qualifications

• Background in management consulting, operational excellence, or Lean/Six Sigma with application to life sciences manufacturing, quality, or regulatory environments.
• Experience in a high-growth or private equity-backed environment with an understanding of how consulting services contribute to enterprise value creation.
• Familiarity with structured selling methodologies and experience applying them in technical consulting sales cycles.
• Knowledge of waste reduction, energy efficiency and compliance-driven operational improvement programs in regulated industries is a plus.
• Advanced degree in a relevant field.

#LI-Hybrid

#LI-JB1

Besides Health, Dental and Vision Insurance, we contribute to a 401k, offer a generous tuition reimbursement program, TONS of safety training for some positions with opportunities for external trainings and certifications, Mentorship & Career Succession Planning, Relocation Opportunities, Auto/Home insurance discounts, pet assistance discount plans, discounted movie passes & more!  

To learn more about our business, culture, and the exciting work that we are doing in the industry, find us on LinkedIn, Instagram (@triumvirateenvironmental), or our website!  

Triumvirate Environmental is committed to a diverse and inclusive workplace. As an Equal Opportunity Employer (EOE), Triumvirate does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individuals with Disabilities and Protected Veterans are encouraged to apply. 

If you have a disability and need accommodation during the application and hiring process, please contact us at https://www.triumvirate.com/contact or call us at 888-834-9697.  The requirements listed above are representative of the knowledge, skill, and/or ability required. To view our California Privacy Notice and Policy, click here. 

Consulting Commercial Leader, Life Sciences and EHS

Triumvirate Environmental is one of the largest integrated environmental services firms in North America, serving the life sciences, healthcare, higher education, and advanced manufacturing sectors. Our model combines on-site embedded personnel, project-based consulting, field services, and waste management into a single platform that delivers comprehensive solutions no pure-play competitor can replicate. With more than 500 embedded professionals working inside client facilities across the country, we maintain deep, enduring relationships with many of the most recognized names in pharmaceutical manufacturing, biotechnology, and medical devices. We are in a significant growth phase, scaling our consulting and professional services division substantially over the next several years.

What sets Triumvirate apart is that we do not just manage waste. We transform it. Our Plastics4Purpose program, built over more than a decade organically and through acquisition, converts tens of millions of pounds of regulated medical and laboratory plastics into commercial products every year. Combined with our embedded personnel who drive daily waste reduction and segregation improvement inside client facilities, and our consulting team who designs the multi-year circularity programs that close the gap between published targets and operational reality, we deliver the kind of self-funding projects that CFOs actively want in their capital plans.

About the Role

The Consulting Commercial Leader is a senior consulting leader who both wins and oversees delivery of complex consulting engagements for clients in life sciences, healthcare, and advanced manufacturing. You will carry a personal book of business targeting $3 million or more in annual revenue while leading the delivery of multi-site, multi-disciplinary consulting programs at scale.

What makes this role different from a traditional consulting partner position is the commercial engine behind you. Our embedded sales organization has built robust multi-decade relationships and proven track records with some of the most exciting companies in pharma and life sciences. They are skilled at opening doors that traditional consulting firms spend years trying to access, and they generate real-time intelligence from inside client operations that no competitor can replicate. Your ability to convert that intelligence into multi-million dollar consulting programs, and to deliver results that strengthen the full client relationship across all of Triumvirate's service lines, is what defines success in this role.

The ideal candidate brings management consulting rigor and deep life sciences domain expertise. We value backgrounds in operational excellence, Lean and Six Sigma, manufacturing process optimization, regulatory compliance, and circularity program design as highly as traditional EHS consulting experience. What matters most is demonstrated experience developing and running multi-million dollar consulting programs for life sciences organizations, including programs that deliver measurable waste reduction, material recovery, and operational cost savings, and the ability to do so at enterprise scale.

This position reports to our Head of Consulting. This role offers a hybrid work model and can be based anywhere on the East Coast between Boston, MA and Raleigh, NC.

Essential Responsibilities

• Build and manage a personal book of consulting business, targeting $3 million or more in annual revenue through a combination of new business development and expansion of existing client relationships.
• Oversee the delivery of complex, multi-site consulting engagements including compliance program assessments, operational excellence initiatives, safety program development, industrial hygiene evaluations, environmental permitting support, and circularity advisory services such as waste characterization studies, waste stream optimization, green laboratory certifications, and multi-year material recovery programs designed with quantified savings and clear payback periods.
• Develop and execute multi-million dollar consulting programs that span multiple client sites, disciplines, and years, managing large-scale engagements with the rigor and structure expected in management consulting environments.
• Develop trusted advisor relationships with VP-level and C-level EHS, operations, quality, and facilities leaders at pharmaceutical, biotech, medical device, and healthcare organizations.
• Collaborate with field sales professionals and account managers to identify and pursue consulting opportunities within Triumvirate's existing client base, leveraging the intelligence generated by on-site embedded personnel.
• Scope, price, and propose consulting engagements that reflect the full value of the client relationship, including circularity programs structured as self-funding initiatives with clear ROI, balancing project margins with the strategic importance of the account across all of Triumvirate's service lines.
• Manage engagement economics including staffing, utilization, scope control, and margin performance. Identify and mitigate scope creep early.
• Recruit, develop, and mentor consulting staff, building a team capable of delivering consistently high-quality work and growing into client-facing roles.
• Contribute to the development of standardized methodologies, proposal templates, and delivery frameworks that improve consistency and efficiency across the consulting practice.
• Represent Triumvirate at industry conferences and client events. Contribute to thought leadership through publications, presentations, and webinars.

Required Qualifications

• 10+ years of progressive experience in life sciences consulting, EHS consulting, operational excellence, or a related professional services discipline, with at least 5 years of direct business development and client management responsibility.
• Demonstrated track record of building and sustaining a personal book of business of $2 million or more annually.
• Experience developing and managing multi-million dollar consulting programs at enterprise scale, including multi-site, multi-year engagements with complex stakeholder environments.
• Technical depth in two or more of the following: occupational safety, industrial hygiene, environmental compliance, process safety, manufacturing process optimization, Lean/Six Sigma, operational excellence, or circularity and waste reduction.
• Experience delivering consulting services to clients in life sciences, pharmaceutical manufacturing, biotechnology, or healthcare settings.
• Strong project management skills with experience managing multi-site, multi-disciplinary engagements with budgets exceeding $500,000.
• Excellent written and verbal communication skills, with the ability to present to executive audiences and translate technical findings into business recommendations.
• Must be eligible to work in the United States without future sponsorship.

Preferred Qualifications

• Background in management consulting, operational excellence, or Lean/Six Sigma with application to life sciences manufacturing, quality, or regulatory environments.
• Knowledge of circularity frameworks, energy efficiency, waste reduction, or compliance-driven operational improvement programs in regulated industries is a plus.

#LI-Hybrid

#LI-JB1

Besides Health, Dental and Vision Insurance, we contribute to a 401k, offer a generous tuition reimbursement program, TONS of safety training for some positions with opportunities for external trainings and certifications, Mentorship & Career Succession Planning, Relocation Opportunities, Auto/Home insurance discounts, pet assistance discount plans, discounted movie passes & more!   

To learn more about our business, culture, and the exciting work that we are doing in the industry, find us on LinkedIn, Instagram (@triumvirateenvironmental), or our website!  

Triumvirate Environmental is committed to a diverse and inclusive workplace. As an Equal Opportunity Employer (EOE), Triumvirate does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Individuals with Disabilities and Protected Veterans are encouraged to apply. 

If you have a disability and need accommodation during the application and hiring process, please contact us at https://www.triumvirate.com/contact or call us at 888-834-9697.  The requirements listed above are representative of the knowledge, skill, and/or ability required. To view our California Privacy Notice and Policy, click here.