Senior Director, Regulatory Affairs CMC - Gene Therapy

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, and Japanese regulations for biologics, including gene therapy, with the ability to identify the differences in regulations across the regions; 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), including working knowledge of and experience with electronic submissions (eCTD). 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, ideally for orphan/rare disease programs. Experience serving as the Global CMC regulatory lead on a multifunctional, cross-functional development team, with the ability to assess CMC regulatory risk, influence strategic decisions, and exercise sound regulatory judgment on novel or ambiguous issues where precedent or explicit guidance may be limited. 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. Strong cross-functional collaboration and communication skills, with the ability to build effective relationships, communicate clearly and concisely, and work successfully in a dynamic, culturally diverse environment. Proven ability to manage multiple priorities in a fast-paced, evolving organization, demonstrating strong planning, organization, attention to detail, and follow-through to meet tight deadlines. High initiative, flexibility, and sound judgment, with the ability to navigate ambiguity, solve problems independently, and uphold high ethical and compliance standards. Nice to Have (but not required): Advanced degree (Master's, PhD, PharmD) preferred. RAC certification desired. Knowledge of neurology and/or ophthalmology drug development desired. Post approval life cycle management desired. Where You’ll Work This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected. Travel Requirements This position involves occasional domestic and/or international travel (approximately 10%). #LI-Remote #LI-MM Pay Range: $222,000.00-303,000.00 Annual Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: 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 with purposeful in-person collaboration 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance 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 Eligibility for specific programs may vary and is subject to the terms and conditions of each plan. Current Insmed Employees: Please apply via the Jobs Hub in Workday. Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical