Senior Director, Regulatory Affairs – Gene Therapy

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 on the Regulatory Affairs, Gene Therapy team to help us expand what’s possible for patients with serious diseases. Reporting to the VP, Regulatory Affairs, Gene Therapy you’ll serve as the regulatory lead at the Global Project Team (GPT) for assigned program(s). You may also serve as the regulatory lead at the sub team level, as needed, to support business needs. This role can be onsite, hybrid or remote. What You'll Do: In this role, in collaboration with the VP and program lead, you’ll have the opportunity to define, develop, and implement a well-defined global regulatory strategy plan to facilitate efficient and competitive product development from early to late-stage development through registration and life-cycle management. You’ll also: Provide expert analysis and strategic guidance on regulatory risks, pathways, and policy shifts to ensure program objectives are met Actively participate in cross-functional decision-making discussions to ensure potential regulatory impact on product development and lifecycle management are communicated and considered Proactively identify and communicate potential risks and define mitigation strategy to prevent, or minimize, their impact to assigned program(s) Lead overall strategy and preparation of key regulatory dossiers including, but not limited to, meeting requests, briefing documents, Orphan drug applications, INDs, CTA/CTRs, CTNs, and applications for expedited pathways (fast track, RMAT, etc.) as needed Lead monthly Global Regulatory Team meeting Present regulatory strategy at cross-functional team meetings and to senior leadership, upon request Monitor the evolving regulatory competitive landscape to identify potential opportunities and areas of risk to assigned programs Interpret complex regulatory regulations/guidance’s to inform development plans and potential impact to key stakeholders In concert with the regulatory policy lead, influence regulatory environment via commenting on draft guidance’s of direct interest to Insmed’s gene therapy portfolio Regulatory technical writing and review of documentation prepared by other technical functions (nonclinical, clinical and CMC) supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.) in accordance with regulatory guidelines/requirements Provide leadership and management for the coordination and preparation of submissions consistent with regulatory requirements and in accordance with corporate strategy and timelines Ensure accurate archiving of correspondence and submissions, and manage vendor/consultant roles, where applicable. Serve as the primary contact with FDA, guide and/or lead complex interactions with regulatory and health agencies (e.g., FDA) on critical regulatory matters Mentor junior regulatory professionals and support a culture of continuous learning, cross-training, and operational excellence. In partnership with assigned regulatory lead and regulatory operations, and/or third-party service providers, ensure high quality, complaint, on-time submission activities related to initial regulatory filings and application maintenance e.g., IND/CTA/CTR, information amendments, SAE reports, etc.) Who You Are: You have a Bachelor’s degree alon ... (truncated, view full listing at source)