[Hiring] Senior Director, Regulatory Affairs CMC - Gene Therapy @Insmed Incorporated

Role Description

We’re looking for a Senior Director, Regulatory Affairs CMC – Gene Therapy to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory Affairs Neuro/Other Rare, the Senior Director will serve as the regulatory lead at the CMC sub team level and as an ad hoc member to the Global Program Team (GPT).

In collaboration with the program Regulatory Affairs GPT lead, this individual will define, develop, and implement a well-crafted global regulatory CMC strategy plan to facilitate efficient and competitive product development from early to late-stage development through registration and life cycle management.

What You'll Do:

• Actively participate in cross-functional decision-making discussions to ensure potential regulatory impact on CMC quality development and lifecycle management are communicated and considered.
• Proactively identify and communicate potential CMC risks; define and implement mitigation strategies to prevent or minimize impact to assigned program(s).
• Lead overall CMC regulatory strategy and the preparation of key regulatory dossiers, including meeting requests, briefing documents, INDs, CTA/CTRs, and CTNs, as needed.
• In partnership with the assigned Global Regulatory Lead, Regulatory Operations, and/or third-party service providers, ensure high-quality, compliant, on-time submission activities for initial filings and application maintenance, including IND/CTA/CTR, IMPD updates, and information amendments.
• Provide expert analysis, interpretation, and application of regulatory guidance and requirements from FDA, EMA, PMDA, and ICH, as well as industry and agency best practices and trends, to inform development plans and key stakeholder decisions.
• Monitor the evolving regulatory and competitive landscape to identify opportunities and risks for assigned programs; in partnership with the Regulatory Policy lead, help shape the regulatory environment through comments on draft guidance of direct interest to Insmed.
• Contribute to scientific discussions and collaborations with technical and scientific teams to resolve CMC regulatory issues across development stages and product lifecycles.
• Review regulatory CMC technical documentation prepared by other functions and assess proposed manufacturing, analytical method, raw material, and facility changes for compliance with regional GMP regulations and ICH guidelines.
• Guide and/or lead complex CMC-focused interactions with regulatory authorities and Health Agencies, including FDA, on critical regulatory matters.
• Participate in monthly Global Regulatory Team meetings and serve as the regulatory representative on the specification sub-team; ensure accurate archiving of correspondence and submissions, manage vendor/consultant roles where applicable, and mentor junior regulatory professionals to support continuous learning and operational excellence.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 10+ years’ experience in Global CMC Regulatory Affairs and/or relevant product development experience in the pharmaceutical or biotechnology industry.
• A minimum of 5+ years of gene therapy orphan (rare) drug development experience.
• A solid understanding of US, EU, and Japanese regulations for biologics, including gene therapy.
• Strong working knowledge and direct application of relevant ICH quality/CMC guidance, particularly those pertaining to gene therapy product development.
• Experience in the submission and management of the quality aspects of IND/CTA/CTR/IMPDs and global registration applications (e.g., BLA, J-NDA, and MAA).
• Experience in leading direct interactions with Health Authorities at key milestone meetings and on complex regulatory matters.
• Demonstrated leadership of global CMC regulatory strategy for gene therapies across early development, registration, and post-approval lifecycle management.
• Experience serving as the Global CMC regulatory lead on a multifunctional, cross-functional development team.
• Strong cross-functional collaboration and communication skills.
• Proven ability to manage multiple priorities in a fast-paced, evolving organization.
• High initiative, flexibility, and sound judgment.

Requirements

• Experience partnering with Global and Regional Regulatory leads to ensure local regulatory planning and strategy align with and support the overall Global CMC development strategy.
• Ability to assess CMC regulatory risk, influence strategic decisions, and exercise sound regulatory judgment on novel or ambiguous issues.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support.
• Annual wellbeing reimbursement and access to our Employee Assistance Program (EAP).
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.