Senior Director, Regulatory Affairs CMC - Gene Therapy at Insmed in San Diego, CA

Job description

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: 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: In this role, you’ll have the opportunity to actively participate in cross-functional decision-making discussions to ensure potential regulatory impact on CMC quality development and lifecycle management are communicated and considered. You’ll also: 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. Who You Are: You must have a Bachelor’s degree in a scientific discipline and 10+ years’ experience in Global CMC Regulatory Affairs and/or relevant product development experience in the pharmaceutical or biotechnology industry. Additionally, you have: A minimum of 5+ years of gene therapy orphan (rare) drug development experience. A solid understanding of US, EU, an