Position Overview

Tonix is looking for a full-time Associate Director, Regulatory Affairs to effectively develop regulatory strategies and submission plans. This position would be responsible for leading regulatory activities related mainly for novel biologics or drugs in early phase development (pre-IND and nonclinical experience) to clinical development and marketing application. The Associate Director, Regulatory Affairs can work autonomously and will support all aspects of this process including early phase interactions with regulatory authorities (FDA and/or global), providing direction and actively participating in overall preparation of activities with cross-functional teams to advance the drug development program.

This is a fast-paced challenging position offering a competitive compensation and benefits package.  This position will report directly to the Co-Head of Regulatory Affairs, Management and Execution, and will be based out of a Tonix office or can be a remote based position. 

Key Responsibilities

• Act as Regulatory Lead and Manager for investigational programs in the US or global programs by providing regulatory expertise to advance product development, from nonclinical to clinical and marketing application
• Prepare, review, and co-ordinate regulatory documentation to support early phase development including early phase meetings with Regulatory Authorities and initial IND application and IND amendments to support first-in-human clinical trials
• Manage and prepare complex regulatory submissions, including drafting and review and approval of submission contents, which will require interaction with cross-functional teams and external vendors to ensure timely and quality execution
• Provide regulatory impact assessments to changes to project teams and senior management and recommend strategies and regulatory courses of action
• Follow all established occupational health and safety procedures, GxP and standard operating procedures (SOP’s)
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work as necessary to support the Regulatory function and Tonix on various business initiatives

Qualifications

• Bachelor’s degree in biological or pharmaceutical sciences
• Seven (7) years of experience in pharmaceutical or health care industry experience or equivalent
• Five (5) years in early and late stage regulatory drug development
• Good scientific background and understanding of biology and immunology with the ability to acquire therapeutic area and regulatory knowledge in a short timeframe
• Knowledge of FDA and EU regulations and ICH requirements
• Proven successful leadership and project management experience
• Experience directly writing submission documents that support IND applications, clinical trials, and marketing applications
• Experience developing and implementing regulatory strategies 
• Ability to travel up to 20%
• Dedicated team player who is able to withstand the high demands of a fast-paced environment
• Strong planning and organizational skills and attention to detail with accuracy and quality
• Excellent written and verbal communication skills
• Able to work independently with minimal supervision and collaboratively with team members
• Able to effectively interact with internal and external parties to drive projects through to completion to tight timelines

Position Overview

Tonix is seeking a full-time Senior Director of CMC and Nonclinical Program Management to lead the strategic planning and execution of development programs across Chemistry, Manufacturing, and Controls (CMC) and nonclinical functions. This role will play a critical part in driving decision-making across a complex portfolio of drug development programs, ensuring alignment between program strategy, timelines, budgets, and organizational priorities.

Essential Duties

CMC and Nonclinical Program Mgt.:

• Maintain product supply (non-commercial) and establish manufacturing plans at CDMOs to support preclinical IND enabling activities and clinical studies (all phases of development).
• Identifies and manages program budgets and defines program‑specific development goals and objectives in alignment with the Tonix product portfolio strategy.
• Member of the CMC Project team meetings, both internal and at CDMOs, to ensure effective, efficient product development whilst adhering to all quality and regulatory compliance expectations by ensuring the development team are actively engaged, supporting the technical and quality team members of the project internally and in collaboration with the CDMO and associated contracts.
• Member of the Nonclinical Project Teams, providing project management support to ensure effective, efficient progression of studies and activities in both internal laboratories and at CROs.
• Assist Project Teams with stage-gate transition across key discovery and development milestones.
• Manage all CMC and Nonclinical regulatory interactions, ensuring source documents are available, amendments and annual reports are delivered on time.
• In collaboration with the internal teams, manage contract review and approval, including request for proposal/information, quarterly accruals, review percent complete vs contracts milestones, and review accuracy of invoices (including all business documentation associated with CMC and Nonclinical activities).
• Oversee CMC and Nonclinical program timelines, risks, milestones, and deliverables, report updates to Senior Leadership Team including cost shifts and scope changes.
• Leads proactive risk identification, assessment, and mitigation activities across all program phases, ensuring alignment with the Risk Management Program and overall program success.
• Collaborate with internal stakeholders and external partners, such as regulatory agencies and contract organizations, to navigate complex development programs prior to commercialization.
• Manages relationships with Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), and other external partners.
• Managing multiple development programs simultaneously while reporting on deadlines and budget.
• Define, develop, and oversee comprehensive program strategies that align with organizational goals, ensuring successful drug development from discovery to commercialization and aligned with the Portfolio Mg. processes and plans.

Necessary Skills and Abilities

• Extensive understanding of Chemistry, Manufacturing, and Controls (CMC) processes, including drug substance and drug product development, analytical methods, formulation, manufacturing, scale-up and validation.
• Expertise in Good Manufacturing Practices (GMP), Quality by Design (QbD), regulations and guidance (FDA, EMA, ICH). Strong emphasis on maintaining product quality and compliance at every development stage.
• Experience with Module 2 & 3 regulatory content to support submissions from development through approval (IND, NDA, BLA) and lifecycle management.
• Strong mentoring and team-building skills to develop high-performing teams. Experience leading and overseeing a team of project managers, fostering development, accountability, and consistent delivery of complex programs.
• Experience in drug development processes, clinical trial design, and preclinical study design combined with strong leadership, communication, and problem-solving skills.
• Ability to align development strategies with organizational goals and industry trends; utilization of standard project management tools including (MS Project, Smartsheet, OnePager, etc.)
• Comfortable navigating uncertainty and adapting to changing priorities in a fast-paced, highly regulated environment.
• Demonstrated experience building and implementing CMC project management programs in a GxP environment with clearly defined stage‑gates, leveraging Tonix Quality and Technical Operations procedures.

Education and Experience Requirements

Position Overview:

The Manager, Quality Systems & Administration, situated within the Quality Assurance department, will provide support for the Veeva electronic Document and Quality Management systems (QDocs, Training, eQMS, and RIM) systems.

This position will be responsible for providing ongoing system administration, access management, configuration, and maintenance activities, as well as user support, and ensuring these systems are in an operational state of compliance associated with cGMP manufacturing environments, GxP requirements, and internal policies.

They will ensure consistent application of policies, procedures, and work instructions associated to these systems, as well as adherence to regulatory requirements.  

This position will also manage the reconciliation and archiving process of paper documents, electronic signature workflows (e.g. DocuSign), document uploads into Veeva QDocs in support of area departments as needed.

The Manager, Quality Systems & Administration will collaborate cross-functionally for on-going activities in support of continuous improvement initiatives system and workflow enhancements and assist in any other area as needed or directed by management.

Responsibilities:

• Perform Business Administrator activities in the Veeva Quality Management Systems (QDocs, Training, eQMS, & RIM), including management of user roles, permissions, and access controls.
• Provide configuration support of Veeva Vault Quality modules (e.g., QMS, Docs, Training), including management of document lifecycles, workflows, templates, and metadata.
• Participate in the assessment of impacts related to configuration changes and/or, system releases. Execute user test scripts related to system changes, as needed.
• Work with other Veeva System Leads and Veeva System Administrators to ensure continuity across workstreams
• Manage document and/or event workflows to support end users.
• Manage and/or support electronic signature workflows and envelopes (e.g. DocuSign), and document uploads into Veeva QDocs in support of area departments as needed.
• Support user training sessions, onboarding, and refresher training for Veeva Vault applications. Assign and/or revise user training plans and curricula in alignment with area department needs, as appropriate.
• Support the reconciliation and archiving process of paper documents.
• Identify opportunities to enhance system usability, workflow efficiency, and user experience.
• Perform other projects related to the improvement of quality systems as needed and required by management, including the Veeva eQMS system.
• Participate in regulatory inspection, internal audits, supplier audits (as needed), and audit response activities.
• Ensure compliance with all applicable policies, procedures, and regulatory requirements

Necessary Skills and Abilities:

• Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME-level experience administering and configuring Veeva Vault is required.
• Working knowledge of GxP processes associated with Veeva Quality Docs, Training, eQMS, and RIM applications (e.g., document change control, training, deviation management & CAPA).
• Proficiency in Microsoft office applications, including formatting of MS Word document & Excel spreadsheets.
• Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and non-technical stakeholders
• Dedicated team player who is able to withstand the high demands of a fast-paced environment.
• Excellent planning and time management skills and the ability to handle several tasks simultaneously.
• Comfortable working independently with minimal supervision.
• Strong troubleshooting and problem-solving skills.
• Excellent communication skills with the ability to collaborate across functional teams Must lead by example through strong work ethics and high standards.
• Ability for travel up to 10% of the time

Qualifications

• Bachelor’s degree or higher.
• 8+ years of experience in the biotech/pharmaceutical industry, with a minimum of 4 years situated within a Quality Management Systems function or equivalent.
• Extensive experience in Veeva Vault Systems Administration and configuration.
• Experience with previous implementation of Veeva Vault platforms and systems migration.

Preferred:

• Experience in managing a document archival room and coordination with off-site storage procedures.
• Experience in executing test scripts to support system updates and releases.
• Experience with Veeva PromoMats, and/or other EDMS/QMS/LMS systems.

Position Overview

The Senior Specialist, Regulatory Operations, will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases.

You’ll work closely with Regulatory Affairs and cross-functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization. This position will report directly to the Senior Director of Regulatory Affairs and will be based out of a Tonix office or can be a remote based position. 

Essential Duties

• Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables.
• This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities.
• Serve as submission manager and primary contact for publishing vendors and internal stakeholders.
• Oversee regulatory document management, tracking, and archival activities.
• Manage regulatory systems (e.g., Veeva RIM, PromoMats), and serve as internal subject matter expert (SME) for training and support to internal stakeholders
• Develop and implement processes, templates, and tools that improve submission efficiency and consistency.
• Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases.
• Provide subject matter expertise on regulatory technologies and submission best practices.
• Monitor new regulations and industry trends to assess impact on operational practices.
• Any other supporting activities or research, as needed, for the regulatory team.

Necessary Skills and Abilities

• Experience managing outsourced publishing vendors a plus.
• Skilled at balancing strategic oversight with hands-on execution.
• Strong communicator and collaborator with excellent organizational skills.
• Ability to travel 10% of the time

Educational Requirements

• Bachelor’s degree in a scientific or related field.

Experience Requirements

• 3-4 years of regulatory operations experience in biotech or pharmaceutical industry.
• Strong understanding of eCTD submission standards and regulatory requirements across global regions.
• Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management.
• Hands-on experience with Veeva RIM and/or PromoMats strongly preferred.