About the Role

• OSD Operator plays a critical support role in Oral Solid Dosage (OSD) formulation development, working closely with formulation scientists to execute laboratory‑scale manufacturing activities in a safe, compliant, and well‑documented manner. The role focuses on operating and maintaining OSD equipment, supporting formulation trials, and ensuring strict adherence to GLP, SOPs, data integrity, and EHS requirements

Key Responsibilities

OSD Operations & Equipment Handling

• Operate and support laboratory‑scale OSD equipment including dispensing, granulation, FBP, HME, blending, compression, and coating as per approved SOPs and protocols.
• Set up, monitor, and clean OSD equipment such as blenders, granulators, compression machines, coating pans, and associated accessories under supervision.
• Support formulation trials, optimization studies, and batch execution activities
• Calibration, Maintenance & Equipment Compliance
• Perform daily calibration / verification of balances and pH meters and ensure proper documentation in logbooks
• Ensure timely annual calibration and preventive maintenance of formulation equipment in coordination with Instrumentation / Engineering teams
• Identify, label, isolate, and report equipment malfunctions, deviations, or abnormal performance immediately.
• Comply with EHS requirements, PPE usage, and safe material handling practices.
• Support handling of raw materials during batch operations and disposal of expired or discarded chemicals as per SOP.
• Report safety observations, incidents, or near misses immediately.
• Ensure Cleanliness, Hygiene, OSD and injectable lab as per the cGMP practices.
• Daily Temperature & Humidity monitoring in Lab Refrigerator & Freezer and retrieving the Data Backup in frequent intervals.
• Preparation of RGP & NRGP in coordinating with technical team and providing numbering for the Same and maintaining a Track.
• Ensure the receipt of the material at respective CRO & CMO.
• Follow up for the materials which were sent out through RGP.
• Maintenance of minimum spares related consumable items in co-ordination with the Warehouse team.
• Maintaining adequate facilities in the site for Collection, Storage and Disposal of Hazardous & Non-Hazardous Waste from the Site to authorized third parties in co-ordination with the EHS department.
• Shall Fulfill and support all the EHS requirements at the site.

Required Skills and Experience

• 8+ years of experience as a Working Professional in similar field.

Preferred Qualifications

• Shall hold any bachelor’s degree relating to science or equivalent.

Role and Responsibilities

Role: Responsible for development and implementation of new and revised pharmaceutical drug product labeling for both pipeline and commercial products across global market (including FDA, EMA, Health Canada, GCC, APAC, LATAM, and other emerging regions) ensuring compliance with applicable regulations, guidelines, and company standards.

Key Responsibilities

• Oversee regulatory labeling activities across the entire product lifecycle from development through post-approval, ensuring timely submissions and adherence to international health authority requirements.
• Act as a subject matter expert for global labeling regulations, standards and best practices.

 Responsibilities: 

• Initiate and monitor the process for new and revised labeling requests according to internal procedures.
• Prepare and update labeling components such as SmPC, PIL, USPI, carton/container labels, and electronic formats (e.g., SPL, XML) for global submissions.
• Ensure regulatory compliance, accuracy, and version control of all new and revised labeling.
• Coordinate, monitor, and expedite labeling changes to meet established deadlines for HA submission and/or production schedules.
• Coordinating with artworks preparations team for development of label / cartons / package insert for submission purposes.
• Initiate and approve change controls for new and revised labeling.
• Participate in Azurity’s Labeling Management Review Committee (LMRC) weekly meetings to finalize and approve labeling.
• Develop collaborative and respectful relationships with internal and external customers, including but not limited to, Packaging Operations, Marketing, Medical Affairs, Regulatory Affairs, Supply Chain, and artwork and print vendors to develop labeling.
• Monitor and update the labeling tracker to ensure timely progress and adherence to project timelines.
• Monitor global regulatory changes, guidance documents, and safety updates that impact product labeling.
• Archive controlled label copies and master label files according to internal procedures.

Required Skills and Experience

• Ability to read, understand, and follow HA regulations and guidance documents related to labeling.
• Proven experience collaborating within cross-functional teams to achieve shared objectives.
• Strong attention to detail and ability to meet deadlines
• Highly skilled at prioritizing and managing multiple tasks simultaneously.
• Strong interpersonal skills and an effective communicator (phone, email, web-ex, video, in person)
• Strong sense of teamwork, ability to build collaborative relationships.
• Adept at identifying, addressing, and escalating issues promptly to ensure resolution.
• Familiar with Regulatory Information Management (RIM) systems like Veeva Vault and/or similar platforms.
• Ability to work with large datasets and detailed documentation.

Preferred Qualifications

• 8-12 years of pharmaceutical labeling experience.
• Bachelor’s/ Master’s degree in scientific discipline preferred.

About the Role

Azurity is seeking an Associate Director to manage QA Operations internationally to ensure full compliance with US FDA, EU GMP, Health Canada, PIC/S and GDP regulations and guidelines. As part of these core responsibilities, this role will support Global Quality Operations including deviation/OOS assessment, CAPA management, change control, PQR reviews, product complaints, performance of vendor audits, and technical batch release, as applicable.

Key Responsibilities

• Lead QA oversight for assigned CMOs, 3PLs and other types of vendors based Internationally, including deviation/OOS assessment, change control, and CAPA evaluation.
• Oversee technical documentation for batch disposition (e.g. batch record reviews, CoAs, deviation/OOS investigation reports, stability data) to support in-market product release.
• Ensure quality processes align with international standards and local market requirements.
• Collaborate with Supply Chain, Regulatory, Technical Operations, for the supply of medicinal products to the various markets.
• Oversee Quality Management System for assigned vendors: deviation investigation, CAPAs, change control management, product quality reviews (PQRs), compliance risk assessment, self-inspections, and Quality Technical Agreements.
• Support inspections from the local Health Authorities and follow-up actions
• Conduct GMP/GDP audits of CMOs, 3PLs, and other vendors.
• Participate in local risk management and escalation processes aligned with global procedures.
• Lead continuous improvement and training of QA personnel related to regulatory/compliance requirements.
• Lead a team of QA Operations personnel.

Required Skills and Experience

• Minimum 10 years in pharmaceutical Quality Assurance / QA Operations (QC experience would be eligible)
• Previous experience in managing external pharmaceutical manufacturing partners (CMOs).
• Team management experience.
• Working knowledge of Veeva Quality Vault (Quality Management System) is beneficial.

Preferred Qualifications

• Degree in pharmacy, chemistry, or biology or any other related science background.

Brief team/department description:

Technical Operations is responsible for management and oversight of technical process strategy, CDMO management, and execution of product deliverables in alignment with Azurity policies and objectives. The position leads staff and contractors and collaborates cross-functionally to achieve project milestones in support of process analytical method developments, analytical method validations, analytical method verifications and validations, method verification of excipients, packaging materials, scale-ups and process validation, technical transfers, implementation of lifecycle post approval changes, and investigation / closure of deviations / OOS for commercial products.  This position ensures the post registration development activities, tech transfers, validation / launch and product post approval change projects are driven to success across CDMO network. This role is responsible for complete cycle project deliverables specific to Analytical activities   to the product transfers, scale-up to manufacturing sites, and commercial manufacturing of drug products.

Principle Responsibilities:

• Draft / Review / Approve analytical method transfers, validations, verifications documentation to ensure correct implementation of validation strategy.
• Provide on-site CMO oversight during execution of analytical method transfers, validations, verifications activities to ensure alignment with approved strategy and documentation in support of Tech Transfers, product validations and product lifecycle changes.
• Serve as the Tech Ops analytical Lead and coordinate with the Azurity cross-functional and CMO teams during preparation for and execution of analytical method transfers, validations, verifications needed for post-registration scale-up and engineering batch manufacturing and, and process qualifications batches.
• Prepare / support CDMO RFQ/RFP as needed to support opportunities for technology transfer, scale-ups, validation, and post approval changes. Review and approval of proposals for post registration CDMO activities with reference to the analytical activities.
• Coordinate with CMOs for CMC documents needed in support of regulatory filings. Timely review of m3 sections for accuracy prior to filing
• Review due diligence documentation and provide feedback on red flags and value erosion findings to Business Development team in support of opportunities. Timely communications through due diligence trackers, summary of findings, etc.
• Review and approve (as applicable) post approval product deviations / OOS / complaint investigations. Support root cause analysis and determination of CAPAs in support of issue resolution.
• Review, provide technical assessment and support the implementation of post approval changes and support documentation at CMOs.
• Oversee all analytical activities required for supporting product development at Development lab and/or Contract Research Organization (CRO), CTL and/or CMO/CDMO.
• Provide guidance for analytical method development and method verification to analytical scientists.
• Review of analytical raw data ensuring maintenance of data quality throughout product development and lifecycle.
• Review of standard operating procedures pertaining to analytical activities at CMO/CRO network.
• Review of specification, Analytical Test methods, method verification/validation protocol, and reports CTL, and/or CMO/CDMO.
• Review of Drug Master File (DMF) provided by Active pharmaceutical ingredient (API) vendor and
  co-ordinate with them to address any deficiency specific to analytical if applicable.
• Evaluation of impurities from various sources, finalizing the source.
• Draft and/or Review of various CMC study protocols and reports, e.g., ICH stability study, photo-stability study, hold time study, in-use study.
• Preparation and review of the Risk assessment report and justification reports like chiral purity chiral purity, residual solvent justification, elemental impurities risk assessment, Nitrosamine risk assessment, etc.
• Troubleshooting of technical areas pertaining to analytical activities at CRO, CTL, and/or CMO/CDMO, and if required, visiting these sites for the same.
• Review of Quality management system (QMS) documents such as change controls, deviations, out of specifications for CRO, CTL, and/or CMO/CDMO.
• Responsible for addressing all analytical queries/deficiencies arising from regulatory authorities specific to assigned products.
• Responsible for monitoring of overall periodic Pharmacopeial updates of assigned products for API, excipients and drug products.
• Assessment of CRO, CTL, and/or CMO/CDMO suitability for Analytical capability.
• Audit the contract research organization, contract testing laboratory and contract manufacturing organization, active pharmaceutical site to Azurity projects and preparation of audit reports

Qualifications and Education Requirements

• Bachelor’s degree in Life Sciences (Master’s Degree preferred), or related field.
• Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry working directly with analytical instrumentation and methodologies. 
• Expertise in cGMPs, ICH, USP and Validation related requirements and guidances
• In-depth experience in performing analytical / microbial method transfers, validations, verifications, etc., supporting multiple dosage forms (solid oral, liquid oral, injectables, etc.)
• Basic understanding of multiple validation disciplines including manufacturing process validation of multiple dosage forms, cleaning validation, packaging validation, , terminal sterilization validation, hold time studies, shipping studies, equipment / utilities qualification, and facilities validation, with in-depth expertise in analytical methods validation.
• Ability to work in a strategic, tactical, and hands-on level.
• Candidate must be proficient in Microsoft Word, Excel, and Powerpoint.
• Experienced in participating in regulatory agency inspections.

Brief team/department description:

Azurity Pharmaceuticals is seeking an Associate, Drug Safety – Quality, Standards & Training to support drug safety quality systems, standards, audits, and training activities within the Global Drug Safety organization. This role is integral in maintaining inspection readiness, supporting compliance with global pharmacovigilance (PV) regulations, and enabling consistent execution of drug safety processes through effective documentation and training.

Reporting to the Manager, Drug Safety Compliance this associate-level role will work closely with Drug Safety Operations, Compliance, Quality, and cross-functional partners to support SOP management, training coordination, and continuous improvement initiatives.

Principle Responsibilities:

• Support the maintenance and administration of Drug Safety SOPs, work instructions, and standards, including document updates and version control.
• Support coordination of Drug Safety training programs, including onboarding and periodic refresher training.
• Track training completion, maintain training records, and support reporting of training compliance metrics.
• Support preparation for regulatory inspections internal and external audits related to pharmacovigilance.
• Assist with organization and maintenance of inspection-ready documentation and training records.
• Partner with Drug Safety Operations, Compliance, Quality, Regulatory Affairs, and Clinical teams to support consistent application of standards and training requirements.
• Serve as a point of coordination for quality- and training-related communications within Drug Safety.
• Support global Drug Safety initiatives that require standardized processes or training support.

Qualifications and Education Requirements

• 1–3 years of experience in pharmacovigilance, quality, compliance, training, or related roles within pharmaceutical, biotech, or regulated healthcare environments.
• Experience supporting quality systems, SOPs, and/or training coordination preferred
• Must have a clear understanding of pharmacovigilance and regulated quality environment.

Education

• Bachelor’s degree required in Life Sciences, Healthcare, Quality, Training, or related field.

About the Role

The Manager of Medical Information is a key member of the Medical Affairs team who leverages therapeutic and product knowledge to oversee internal and external communication on Azurity products, including the management of unsolicited medical information requests from health care providers (HCPs) and other external stakeholders. This person will provide medical/scientific input to cross-functional teams and will also be responsible for contributing to creating reports and various scientific communications. It is expected that this candidate will develop strong expertise in Azurity’s relevant therapeutic areas.

 Key Responsibilities

• Provide clinical and technical product knowledge in response to clinical/medical inquiries from external and internal customers
• Respond with a sense of urgency and ensure accurate, timely, and appropriate verbal and written responses to unsolicited medical information inquiries from HCPs, payers and managed healthcare organizations, which are not covered by existing responses
• Help support the MI team with providing guidance to the Medical Information Call Center, including but not limited to, helping with escalated cases and providing on-going training/coaching to ensure excellent customer service by the call center staff
• Develop and maintain a product knowledge database, including standard response letters (SRLs) and “frequently asked questions” (FAQ) documents by utilizing the highest level of scientific data so that HCPs can make informed and educated clinical decisions about Azurity’s products
• Analyze reports and metrics to identify trends, insights and knowledge gaps and provide quarterly updates to internal stakeholders
• Review new and relevant data so that content is updated proactively resulting in the most current information in medical information resources for Medical Affairs colleagues and call center staff to share with HCPs regarding Azurity’s products
• Collaborate with internal partners to support both the Promotional Material Review Committee (PMRC) and Scientific Review Committee (SRC), to ensure the provision of medical information is accurate and scientifically balanced
• Build a strong relationship and partnership with internal stakeholders (Clinical Development, Commercial/Marketing, Regulatory, Legal, Quality Assurance, Market Access, etc.)
• Collaborate with the broader Medical Affairs team to assist with topic-specific presentations to share new information regarding a product/disease state or help fulfill knowledge gaps
• Assisting with coordinating, escalating and reviewing legal contracts relating to Medical Affairs activities
• Perform other Medical Information-related support and expanded functions, as required

Required Skills and Experience

• A minimum of 1 or more years’ professional experience in Medical Affairs/Medical Information in a pharmaceutical company or 3+ years in a contact/call center working on behalf of a pharmaceutical company

 Preferred Qualifications

• An advanced degree in health sciences (e.g., PharmD, PhD) with a thorough grasp of the pharmaceutical industry is preferred. Masters or bachelor’s level degree in health sciences (e.g., RN, RPh, PA, NP, etc.) would be considered
• Medical/Drug Information postdoctoral training/fellowship in specialty OR residency and/or postdoctoral training in a clinical practice/pharmaceutical industry setting is preferred.

Brief team/department description:

The Manager, Promotional Material Review Committee, is responsible for managing and supporting the end-to-end operations of the Promotional Review Committee (PRC/MRC). This role is responsible for ensuring promotional materials are reviewed efficiently, consistently, and in compliance with regulatory, medical, and legal requirements while enabling timely commercial execution. Reporting to the Director, Medical Education, this role will partner closely with Medical Affairs, Regulatory, Legal, Compliance, and Commercial teams to drive operational excellence, governance, and inspection readiness across promotional review processes.

Principle Responsibilities:

• Manage day-to-day operations of the Promotional Material Review Committee (PRC/MRC), including scheduling, agenda management, and documentation.
• Coordinate review of promotional materials across channels (e.g., HCP, DTC, digital, print, training materials).
• Ensure clear communication of review outcomes, required revisions, and final approvals to stakeholders.
• Translate complex clinical and scientific data into clear, balanced, and compliant medical content for internal and external audiences.
• Support product launches and lifecycle management through review and creation of foundational medical materials.
• Partner with PMRC/SRC stakeholders to facilitate timely review and approval of materials.
• Collaborate closely with Medical Affairs, Regulatory Affairs, Legal, Compliance, Commercial, and Field Medical teams.
• Serve as a medical content subject-matter partner while maintaining appropriate separation between promotional and non-promotional activities.
• Identify opportunities to enhance content quality, efficiency, and alignment with evolving best practices.

Qualifications and Education Requirements

• 5+ years of experience in promotional review, regulatory affairs, medical affairs operations, or compliance within pharmaceutical or biotech organizations.
• Bachelor’s degree required; advanced degree (PharmD, PhD, MD, or MS) in life sciences or related field preferred.
• Experience supporting or managing Promotional Review Committees (PRC/MRC) strongly preferred.
• Familiarity with FDA promotional regulations, OPDP guidance, and advertising/promotion standards.
  
  

About the Role

Azurity is seeking a Manager to execute QA Operations internationally to ensure full compliance with US FDA, EU GMP, Health Canada, PIC/S and GDP regulations and guidelines. As part of these core responsibilities, this role will support Global Quality Operations including deviation/OOS assessment, CAPA management, change control, PQR reviews, product complaints, performance of vendor audits, and technical batch release, as applicable.

Key Responsibilities

• Execute QA oversight for assigned CMOs, 3PLs and other types of vendors based Internationally, including deviation/OOS assessment, change control, and CAPA evaluation.
• Perform technical documentation for batch disposition (e.g. batch record reviews, CoAs, deviation/OOS investigation reports, stability data) to support in-market product release.
• Ensure quality processes align with international standards and local market requirements.
• Collaborate with Supply Chain, Regulatory, Technical Operations, for the supply of medicinal products to the various markets.
• Manage assigned vendors for Quality Systems - deviation investigation, CAPAs, change control management, product quality reviews (PQRs), compliance risk assessment, self-inspections, and Quality Technical Agreements.
• Support inspections from the local Health Authorities and follow-up actions.
• Support GMP/GDP audits of CMOs, 3PLs, and other vendors, if required.
• Participate in local risk management and escalation processes aligned with global procedures.
• Execute continuous improvement and training of QA personnel related to regulatory/compliance requirements.

Required Skills and Experience

• Minimum 5 years in pharmaceutical Quality Assurance / QA Operations (QC experience would be eligible)
• Previous experience in managing external pharmaceutical manufacturing partners (CMOs).
• Working knowledge of Veeva Quality Vault (Quality Management System) is beneficial.

Preferred Qualifications

• Degree in pharmacy, chemistry, or biology or any other related science background.

Brief team/department description:

Medical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Working at Azurity offers a unique opportunity that combines the fast pace and growth opportunities of a startup with intellectual rigor and creativity.

The Medical Affairs Manager – CORE (Cardiovascular, Obesity, Renal, Endocrinology) is a Hyderabad-based office position within the Medical Affairs Department, reporting to the Medical Lead for the CORE Franchise. The Medical Affairs Manager is responsible for supporting medical strategy to support the safe, effective, and evidence-based use of the company’s products. This role serves as a scientific expert and key liaison between internal teams and external stakeholders, including healthcare professionals (HCPs), key opinion leaders (KOLs), and academic institutions.

Principle Responsibilities:

• Support integrated Medical Affairs strategy aligned with brand objectives and overall corporate priorities.
• Provide scientific and clinical expertise across the full product lifecycle, including pre‑launch planning, launch execution, and post‑marketing support.
• Ensure all medical activities are conducted in accordance with applicable regulatory, legal, compliance, and ethical standards.
• Support and sustain strong relationships with key opinion leaders (KOLs) and other external scientific stakeholders.
• Plan and Support advisory boards, investigator meetings, and scientific symposia to advance scientific understanding and gather actionable insights.
• Support the development, review, and approval of medical materials (e.g., slide decks, FAQs, training content, scientific response documents) and participate in publication planning and execution (abstracts, posters, manuscripts) in close collaboration with Scientific Communications.
• Support stakeholder engagement and education planning in close collaboration with Medical Leads and Stakeholder Engagement Lead 
• Provide strategic medical input into congress planning, scientific content, and on‑site execution.
• Partner cross‑functionally with Clinical Development, Regulatory Affairs, Commercial, Market Access, and Pharmacovigilance to ensure aligned and effective execution of medical strategy.
• Support sales and internal teams through medical training, scientific education, and ongoing clinical guidance.
• Support real‑world evidence (RWE), investigator‑initiated studies (IIS), and post‑marketing studies in collaboration with Clinical Development as needed
• Collaborate with field medical team to analyze medical insights from external engagements to inform medical strategy and lifecycle planning
• Apply all Medical Affairs SOPs, regulatory, legal, and compliance guidelines while executing activities.
• Demonstrate adaptability, focus, and composure in fast-paced settings while operating with minimal direction.

Qualifications and Education Requirements

• Education:
• Advanced terminal degree (PharmD, PhD, MD, DO) OR other advanced medical degree (NP, PA, etc.) w/ 2+ years relevant therapeutic area clinical experience is required.
• Experience:
• 2-3 years relevant work exp (clinical, fellowship, or research experience) and/or related pharmaceutical industry work experience is required.
• Skills:
• Thorough knowledge or experience in cardiology and/or endocrinology is preferred
• Excellent interpersonal and communication skills with a passion for excellence
• Demonstrated ability to present effective and influential oral presentations
• Deep scientific expertise - stays abreast of data, treatment trends, and new information in the profession and ability to articulate therapeutic knowledge and translate expert feedback into appropriate insights
• Strong strategic and operational thinking skills, with the ability to manage effective networks
• Ability to work effectively in a time and independently
• Highly collaborative team player with experience working across cross-functional teams.
• Excellent organization skills and decision-making abilities. Skillfully plans, prioritizes, and executes multiple responsibilities and projects.
• Knowledge of relevant US healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends.
• Proficiency in digital tools.

Brief team/department description:

Medical Affairs at Azurity Pharmaceuticals, a privately held company delivering innovative medicines for overlooked patients across 50+ countries, drives scientific and clinical initiatives with a portfolio of 30+ brands spanning 10 dosage forms and 9 therapeutic areas. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Working at Azurity offers a unique opportunity that combines the fast pace and growth opportunities of a startup with intellectual rigor and creativity.

The Medical Affairs Manager – Oncology is a Hyderabad-based office position within the Medical Affairs Department, reporting to the Medical Lead for the Oncology Franchise. The Medical Affairs Manager is responsible for leading and executing medical strategy to support the safe, effective, and evidence-based use of the company’s products. This role serves as a scientific expert and key liaison between internal teams and external stakeholders, including healthcare professionals (HCPs), key opinion leaders (KOLs), and academic institutions.

Principle Responsibilities:

• Develop and execute an integrated Medical Affairs strategy aligned with brand objectives and overall corporate priorities.
• Serve as a scientific and clinical expert across the full product lifecycle, including pre‑launch planning, launch execution, and post‑marketing support.
• Support and sustain strong relationships with key opinion leaders (KOLs) and other external scientific stakeholders.
• Plan and support advisory boards, investigator meetings, and scientific symposia to advance scientific understanding and gather actionable insights.
• Support the development, review, and approval of medical materials (e.g., slide decks, FAQs, training content) and support publication planning and execution (abstracts, posters, manuscripts) in close collaboration with Scientific Communications.
• Support stakeholder engagement and education planning in close collaboration with Medical Leads and Stakeholder Engagement Lead 
• Provide strategic medical input for conference planning, scientific content, and on‑site execution.
• Partner cross‑functionally with Clinical Development, Regulatory Affairs, Commercial, Market Access, and Pharmacovigilance to ensure aligned and effective execution of medical strategy.
• Support sales and internal teams through medical training, scientific education, and ongoing clinical guidance.
• Support real‑world evidence (RWE), investigator‑initiated studies (IIS), and post‑marketing studies in collaboration with Clinical Development as needed.
• Collaborate with field medical team to analyze medical insights from external engagements to inform medical strategy and lifecycle planning.
• Apply all Medical Affairs SOPs, regulatory, legal, and compliance guidelines while executing activities.
• Demonstrate adaptability, focus, and composure in fast-paced settings while operating with minimal direction.

Qualifications and Education Requirements

• Education:
  • Advanced terminal degree (PharmD, PhD, MD, DO) OR other advanced medical degree (NP, PA, etc.) w/ 1+ years relevant therapeutic area clinical experience is required.
  • Additional oncology-specific certifications (BCOP, AOCNP) highly desirable
• Experience:

• 2-3 years relevant work exp (clinical, fellowship, or research experience) and/or related pharmaceutical industry work experience is required.

• Skills:
  • Thorough knowledge or experience in Hematology/Oncology and/or Immunology is highly preferred
  • Excellent interpersonal and communication skills with a passion for excellence
  • Demonstrated ability to present effective and influential oral presentations
  • Deep scientific expertise - stays abreast of data, treatment trends, and new information in the profession and ability to articulate therapeutic knowledge and translate expert feedback into appropriate insights
  • Strong strategic and operational thinking skills, with the ability to manage effective networks
  • Ability to work effectively in a time and independently
  • Highly collaborative team player with experience working across cross-functional teams.
  • Excellent organization skills and decision-making abilities. Skillfully plans, prioritizes, and executes multiple responsibilities and projects.
  • Knowledge of relevant US healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends.

Brief team/department description:

WPS R&D team at Azurity wish to extend their support to all the Azurity working locations (technical & non-technical) with respect to safety management to keep safety and sustainability as high as possible.  This will help the Azurity teams to reach their 2026 safety and sustainability goals.

Principle Responsibilities:

• Create and implement Global EHS Policies and Procedure to ensure compliance with local (country specific) governing bodies.
• Risk Assessment: Conduct regular safety audits and inspections to identify potential hazards and recommend corrective actions. 
• Training and Communication: Design and deliver training programs for employees on safety procedures and regulatory requirements. 
• Incident Investigation: Investigate workplace accidents and near misses to determine root causes and implement preventive measures.
• Emergency Preparedness: Develop and execute emergency response plans and coordinate regular drills to prepare for potential incidents. 
• Regulatory Liaison: Act as the primary contact for regulatory agencies, managing all required reporting and correspondence.
• Communicate with local authorities like PCB with respect to CFE/CFO/environment statement as per guidelines.
• Experience in local regulatory submissions.
• Documentation: Maintain accurate records of incidents, inspections, and compliance reports for internal and external review.
• Experience in Effluent management & Waste Management.
• Good Knowledge of MSDS and hazard waste management handling.
• Spill and Release management.
• Extending Mandatory training in EHS & ESG to all Azurity employees periodically.
• Monitoring and evaluation of EHS systems / policies at CMO’s and all other offices of Azurity Pharmaceuticals.
• Educate / periodical Job specific training to Azurity employees.
• Experience in handling potent molecules & their OEL categories.
• Since this position supports all Azurity offices and laboratories globally, the candidate must have strong hands‑on experience in establishing and enhancing EHS/ESG systems across diverse environments.

Qualifications and Education Requirements

• Bachelor's degree / post graduate degree in environmental engineering.
• Diploma or equivalent in workplace safety is added advantage
• 10 to 15 years’ experience.
• Good Communication & language skills
• Management skills
• Trouble shooting with respect EHS

Brief team/department description:

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

As we grow and expand, we are building new capabilities to make our processes simpler, faster, and more efficient. We are looking for a dynamic, change-inspired product development Sr. Manager, to execute R&D product development projects, managing external CDMO/CMO, and managing the R&D bench scientists. The role holder will lead the product development, review technical data, prepare and review technical documents, co-ordinate with CDMO’s and CMO’s for smooth technology transfer of projects. This role aligns closely with evolving R&D needs, leveraging a strong working knowledge of pharmaceutical R&D workflows, data and applicable concepts to effectively coordinate with external vendors and internal stake holders.

Principle Responsibilities:

• Oversee all formulation activities required for supporting product development in R&D and/or CRO and/or CMO and/or CDMO.
• Review of data generated in R&D lab ensuring maintenance of data quality throughout product development and lifecycle.
• To supervise and monitor the technical development front and provide timely and accurate inputs necessary on various aspects of the ongoing programs.
• Drafting and/or review of specifications, product development reports, technology transfer protocol and reports prepared by R&D and/or CRO and/or CMO and/or CDMO.
• Review of various trial, pilot, pivotal, confirmation, submission batch documents, e.g., batch manufacturing records, process validation protocols and reports, etc.
• Draft and/or review of various CMC study protocols and reports, e.g., ICH stability study, photo-stability study, hold time study, in-use study, thermal excursion studies, and technical summary report, etc.
• Understand the different product development and tech transfer strategies in consultation with the regulatory and intellectual property requirement.
• To monitor the execution of scale-up batches and submission batches at CMO’s and to present for the batch’s execution at CMO’s if required.
• To supervise the outsourcing in co-ordination with the CFT members.
• Identify the need for regulatory license requirement for manufacturing, testing import and timely communicate such requirements to the concerned CFTs.
• Identify project needs such as equipment, instruments, manpower and escalate for their approvals.
• Carry out timely communication plan with partners and follow up for timely and accurate delivery.
• Conduct the stage gate meeting and internal review with cross functional teams to updating all the key stake holders.
• Ensure documentation compliance according to quality and regulatory requirements.
• Ensure compliance to quality and other policies/systems laid down by organization.
• Responding to all the product development queries deficiencies arising from the regulatory agencies.
• Ensure the relevant self-training in line with the organizational policies.

Qualifications and Education Requirements

• M.Pharm or Ph.D in Pharmacy with minimum industrial experience of greater than 10 years in product development and scale-up of products.
• Preferred areas of expertise is Extended and Sustained Release Oral Solid Dosage forms and Extended and Sustained Release Suspensions (Dry or Liq.) and Immediate Release Oral Suspensions/Solutions.
• Global Product Development Experience is preferred while core area should be US.
• Experience of developing branded and differentiated products – 505(b)(2) category would be preferred.
• Experience of working with CROs/CDMOs would be preferred
• Support the Quality management system (QMS) documents such as change controls, deviations, out of specifications etc.
• Facilitate completion of required training for self and the team.

Job Summary

Azurity Pharmaceuticals is seeking an experienced and seasoned Patent Professional to join the expanding Intellectual Property (IP) team. This role is central to driving global product development and shaping IP strategies that align with Azurity’ s mission of delivering affordable, accessible healthcare solutions. The ideal candidate will combine deep IP knowledge with business acumen, supporting cross-functional initiatives and managing the company’s innovative formulations across key global markets.

Principle Responsibilities:

1. Portfolio Management & Strategy

• Manage the IP portfolio, including patents and trademarks, across multiple jurisdictions.
• Lead the development and execution of IP strategies aligned with R&D and commercial objectives.
• Conduct thorough IP due diligence to support product selection, licensing, M&A, and strategic partnerships.
• Oversee patent life cycle management, including drafting, filing, prosecution, opposition, maintenance, and strategic abandonment.
• Guide new product opportunity identification through an IP lens, enabling lifecycle extension and exclusivity strategies.

      2. IP Due Diligence & Risk Management

• Perform prior art searches, patentability assessments, landscape analysis, and freedom-to-operate (FTO)evaluations.
• Analyze Orange Book-listed patents & Pending Patent Applications and develop IP strategies in compliance with regulatory and legal requirements.
• Generate risk assessment reports & provide IP clearances for proposed formulations, synthesis routes, polymorphs, and manufacturing processes.
• Analyze the IP to develop non-infringement and patent invalidation strategies, including prior art search and claim construction.
• Provide scientific and technical input to attorneys while responding to office actions.

      3. Litigation & Regulatory Support

• Provide strategic support to the Legal team on patent litigations, including IPR (Inter Partes Review) and PGR (Post-Grant Review) proceedings.
• Develop claim construction and invalidity arguments, leveraging prior art and technical literature.
• Monitor ongoing litigations, especially within the U.S., and assess potential business impact.

     4.Cross-functional Collaboration

• Collaborate with the R&D team to identify patentable inventions and formulate patentable strategies.
• Partner with the R&D team to identify opportunities for differentiated product filings, including 505(b)(2) and ANDA strategies.
• Engage with relevant stakeholders (R&D, Regulatory, Clinical & Legal teams) to define acceptable IP goals.
• Support the development of alternate or workaround strategies for blocking IP.
• Conduct literature reviews (patent and non-patent) to support R&D and IP analysis.

     5.Market & Competitive Intelligence

• Continuously monitor market trends, IP filings, and competitive developments through SEC filings, earnings calls, and public disclosures.
• Conduct whitespace analysis and technology mapping to identify new opportunities.

Qualifications and Education Requirements

• Advanced degree in Pharmacy, Life Sciences, Chemistry, or related scientific discipline.
• 10–12 years of relevant experience in Intellectual Property domain within the pharmaceutical or life sciences industry, preferably with a focus on formulations.

Preferred Skills & Attributes

• Deep understanding of global patent systems and procedures (including Indian, US, EP, and PCT).
• Demonstrated expertise in patent analysis, drafting, prosecution, and litigation support.
• Exposure to P-IV litigations is highly desirable.
• Expertise in global IP law, with hands-on experience in patent filing, prosecution, and infringement/invalidity analysis.
• Strong command over FTO analysis, Orange Book navigation, and regulatory IP alignment (including 505(b)(2) applications).
• Excellent analytical, communication, and interpersonal skills with an ability to work effectively in cross-functional and global teams.
• Strong organizational and time management skills, with the ability to manage multiple priorities under tight deadlines.
• Strong analytical and problem-solving skills with a proactive mindset.
• Strong interpersonal and communication skills for effective cross-functional collaboration.
• Demonstrated ability to influence and negotiate within multidisciplinary teams.
• Comfort working across multiple time zones and adapting to a dynamic, fast-paced environment.

Azurity is seeking an experienced in-house counsel to support its Global Infrastructure Function, which includes Finance, IT / Digital, Work Place Services, HR, EPMO, etc. The legal responsibilities for this role include statutory compliance (for the Indian entity), contracts, legal documentation, strategizing, and advisory.

The candidate must be experienced in understanding and working on the legal requirements for Finance, IT/Digital, Workplace Services, HR, and EPMO departments within an organization. They should have expertise in cross-border contracts, dealing with internal stakeholders and counterparties globally, and be well-versed in managing Contract Lifecycle Management Platform. Additionally, the candidate should have strong experience in stakeholder management and communication to effectively coordinate with various stakeholders present globally.

DUTIES AND RESPONSIBILITIES

Stakeholder Management

• Serve as a strong Legal Business Partner for the relevant departments.
• Gain a deep understanding of the business, products, strategies, transactions, and various issues by aligning with the relevant departments.
• Regularly attend meetings, proactively identify legal issues and highlight risks, and provide solutions to mitigate by collaborating with the relevant departments.
• Ensure all legal requirements are completed within stipulated timelines to facilitate smooth transactions for the relevant departments.
• Preemptively track all important dates and events, and take actions accordingly.
• Work closely with India General Counsel and other legal team members.

Contracts

• Draft, review and negotiate contracts (domestic as well as cross border) such as Service Agreements, SaaS Agreements, Consulting Agreements Subscription Agreements, Lease Agreements, Engagement Letters, Offer Letters, Employment Agreements, Scope of Work, Change Orders, Purchase Orders / Terms and Conditions etc., and amendments, addendum, assignment and termination thereof.
• Developing playbook /checklist for the frequently used contracts and ensuring that the agreements are drafted and negotiated as per the playbook / checklist and are executed in timely manner.
• Ensure risk mitigation, protection of intellectual properties, and commercial interests of the organization by way of contracts.
• Inform and guide stakeholders on the interpretation and purposes of contracts related provisions.
• Identify and assist stakeholders with resolution of issues affecting completion of contracts.. Format documents for finalization. Manage the legal contracts folders.
• Gather, quantify, and report on legal department metrics.

Contract Lifecycle Management Platform

As a highly system-driven organization, Azurity has implemented and uses a Contract Lifecycle Management Platform, namely Ironclad

• Manage and oversee Azurity’s contract life cycle using Ironclad, ensuring contracts are properly tracked, stored and managed.
• Support the creation of contracts by gathering and vetting required inputs, including business terms from business and functional owners. Guide internal clients through the contract request process. As intake coordinator, review contract requests and statements of work against
• Perform review of expiring contracts and manage renewals and amendments.
• Be experienced and well versed with Contract Management Platform – similar to Ironclad (if not better)
• Provide advice and support to various departments on matters related to contracts as well as Ironclad.
• Align with legal, finance and business team members to ensure that Ironclad is used in the most efficient manner
• Develop and implement (or assist to) procedures to improve the efficacy of Ironclad
• Act as liaison between internal clients and the legal department for timely processing of contracts. Handle status inquires, process questions, and direct inquiries to the appropriate attorney.
• Metadata abstraction and tagging into the Contract Lifecycle Management Platform – Ironclad.
• Co-ordinating with stakeholders for execution through Docusign.

General Duties

• Conduct legal issue identification, investigate factual issues, and analysis and legal risk assessment.
• Interpret and respond to requests for information, documents, and status-up-dates-from colleagues seeking legal support.
• Preparing various reports and presentations.
• Provide support in transactional due diligence.
• Perform special projects and general support for the Legal Department.
• Any other duties as may be entrusted from time to time

QUALIFICATIONS

• LL.B from a reputed university
• 3-9 years of relevant experience;
• Experience of supporting in-house legal department;
• Highly skilled in Microsoft Office suite; experience in DocuSign and Box.com preferred;
• Strong verbal and written communications skills to enable communication with legal colleagues and stakeholders present globally, particularly in the US, Ireland, and other EU countries.
• Ability to consistently solve problems with a high degree of independent decision-making.
• Strong organizational skills with careful attention to detail.
• Strong interpersonal skills and must be highly team oriented.
• High level of professionalism and ability to maintain absolute confidentiality.
• Ability to build business acumen and understand core elements of the applicable business area.
• Ability to handle multiple complex tasks and high volume of work in a team-based environment and consistently meet deadlines.
• Tech savvy and able to learn new skills necessary to keep pace with an ever-changing landscape.

BENEFITS

We recognize hard work and dedication with benefits offerings that address individual needs. Our comprehensive package of benefits for eligible employees includes the following:

• For a list of benefits, please see our benefits listing on our careers page at www.azurity.com/careers/

Brief team/department description:

The Supply Chain team at Azurity continues to expand as the business grows globally. We are looking to strengthen the team with an experienced and driven Senior Supply Planner who will play a key role in ensuring reliable product supply across our external manufacturing network.

This role operates in a fast‑paced, international environment and requires strong end‑to‑end supply planning expertise, sound judgment, and the ability to work autonomously while collaborating closely with internal and external stakeholders.

Principle Responsibilities:

• Prepare and update monthly supply plans for assigned CMOs based on demand inputs, inventory on hand, open purchase orders (firmed and planned), and lead times
• Issue and maintain Purchase Orders and rolling forecasts to CMOs in line with the approved supply plan.
• Track and follow up on open orders with CMOs to ensure deliveries are aligned with requested dates; highlight delays, changes, or risks.
• Monitor inventory levels against demand and planning parameters and flag potential shortages, excess, or obsolescence risks.
• Support the day‑to‑day management of supply issues, including short‑term replanning activities, order adjustments, and coordination with internal teams.
• Maintain and validate supply planning master data (e.g. lead times, safety stock, MOQ, lot sizes, purchasing conditions) for assigned SKUs.
• Participate in regular planning touchpoints with CMOs and internal stakeholders to align on supply status and upcoming requirements.
• Perform monthly inventory reconciliation, investigate discrepancies, and support corrective actions to maintain inventory accuracy

Qualifications and Education Requirements

• Bachelor’s degree in supply chain management field.
• Proven minimum 4 years of experience in end‑to‑end (E2E) planning within the pharmaceutical industry, including direct interaction with Contract Manufacturing Organizations (CMOs) in an international environment.
• Demonstrated ability to work in a fast-paced environment with shifting priorities and evolving business needs.
• Familiarity with Oracle ERP systems; functional knowledge is an advantage.
• Strong analytical and problem-solving skills, with excellent communication abilities.
• Proven track record of effective collaboration with both internal cross-functional teams and external partners.
• Strong time management skills with the ability to prioritize tasks efficiently.
• Quick learner with a proactive and adaptable mindset.

Brief team/department description:

• The analytical team at R&D is playing an important role in product development of various dosage forms. The analytical team involves different workflows like analytical method development, stability studies, involving method verifications at CMO/CTL and post filling activities.
• This role is with Azurity R&D Analytical Review team, which coordinates all product development team’s analytical documents preparation such as SOP, COA, ATP, Specification and Method of analysis.

Principle Responsibilities:

• Preparation and upload of Standard operating procedures, Spec and MOA in DMS.
• Conducting training for good documentation practices.
• Archival of General analytical documents.
• Conducting SOP training whenever required.
• Notifying pharmacopeia updates to the analytical team and preparing the assessment report.
• Should have exposure in preparing the documents in electronic DMS and tracking of documents review and approval process.

Qualifications and Education Requirements

• Graduate / Postgraduate in Pharmacy or Science.
• minimum of 5 years of experience in pharmaceutical analytical R&D or QC comes under this category.
• Exposure in preparation of key analytical documents. Understating Good Laboratory Practices and Good Document Practices.
• Should have exposure in electronic DMS systems.
• Proficient in written and spoken English

Job Title: Senior Talent Acquisition Specialist (U.S. Professional Hiring)

Department: Human Resources – Talent Acquisition

Location: Hyderabad, India (Onsite – HiTec City, Mindspace Office Complex)

Shift: Night Shift (aligned to U.S. business hours)

Company: Azurity Pharmaceuticals, Inc.

Job Description Summary

Azurity Pharmaceuticals is a fast-growing pharmaceutical company focused on serving patients with unmet medical needs through customized, user-friendly drug formulations. Our success is driven by talented colleagues who bring rigor, creativity, and commitment to everything they do.

The Executive Recruiter based in Hyderabad will be a core member of Azurity’s Talent Acquisition team, responsible for full-cycle recruiting of professional and leadership-level roles in the United States. This role is designed for an experienced recruiter with exceptional English communication skills and a proven record of successfully hiring U.S.-based professional talent across functions.

This position is based in Azurity’s state-of-the-art, brand-new office located in HiTec City within the Mindspace office complex. Working the night shift to align with U.S. stakeholders, this individual will partner closely with hiring managers, HR leaders, and global TA colleagues to deliver a high-quality candidate experience while meeting aggressive hiring timelines.

Key Responsibilities

• Lead full-cycle recruiting for U.S.-based professional and leadership roles, including intake, sourcing, screening, interviewing, offer support, and close.
• Partner closely with U.S. hiring managers to understand role requirements, success profiles, and hiring priorities.
• Develop and execute targeted sourcing strategies using LinkedIn, job boards, referrals, market mapping, and direct outreach.
• Conduct in-depth candidate interviews with a strong focus on communication skills, experience depth, and cultural alignment.
• Present well-qualified candidate slates with clear, insightful assessments to support hiring decisions.
• Manage multiple concurrent requisitions while maintaining speed, quality, and candidate experience.
• Ensure compliance with Azurity recruiting policies, data privacy standards, and applicable employment regulations.
• Collaborate effectively with global TA colleagues to ensure consistent processes and best practices.
• Provide regular status updates, pipeline insights, and risk flags to stakeholders.

Required Qualifications

• Demonstrated success recruiting professional-level roles in the United States, with a strong track record of consistent hires.
• Exceptional English language proficiency, both written and verbal, with the ability to communicate confidently with U.S.-based leaders and candidates.
• Strong interviewing, assessment, and stakeholder management skills.
• Experience managing high-volume and/or complex professional requisitions simultaneously.
• Deep familiarity with U.S. recruiting practices, candidate expectations, and hiring manager partnership models.
• Ability to work night shift hours aligned to U.S. time zones on a sustained basis.

Preferred Qualifications

• Experience recruiting in pharmaceutical, life sciences, healthcare, or regulated industries.
• Prior experience supporting executive, senior professional, or niche skill-set hiring.
• Comfort operating in a global, matrixed organization.
• Experience using modern applicant tracking systems and sourcing tools.

Core Competencies

• Executive presence and professional communication
• Candidate and hiring manager experience focus
• Strong judgment and decision-making
• Attention to detail with ability to connect details to the big picture
• Results-driven, organized, and resilient

Working Relationships

• Reports into the Talent Acquisition leadership team
• Partners closely with U.S.-based hiring managers and HR colleagues
• Collaborates with global TA and HR Operations teams

Azurity Pharmaceuticals is an equal opportunity employer.