Senior Director, Regulatory Affairs CMC - Gene Therapy

What You'll Do

• 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programs; in partnership with the Regulatory Policy lead, help shape the regulatory environment through comments on draft guidance of direct interest to Insmed.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.