Associate Director, Regulatory Affairs CMC

Sarepta Therapeutics
United States, Massachusetts, Cambridge
215 First Street (Show on map)
Apr 14, 2025
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us The Importance of the Role Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Lead for one or more RA CMC development and/or globally marketed products and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts with responsibility for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Provides product strategy and direction to commercial and clinical teams. Facilitates risk identification & mitigation strategies. Oversee activities of junior regulatory personnel. Manage contractual and budgetary responsibilities with best business practices. The Opportunity to Make a Difference Serves as regulatory CMC lead for assigned product(s) for all regulatory CMC responsibilities, including, but not limited to, the development and implementation of regulatory CMC strategy for assigned projects Prepares and reviews submission-ready CMC and marketing registration applications, supplements, amendments, and variations As a member of the project teams, provides CMC regulatory guidance for global development and registration programs (e.g. INDs, CTAs, NDAs and MAAs) Assesses and communicates CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines Serves as regulatory representative for assigned projects at internal meetings as well as at meetings with regulatory agencies for all CMC related issues Manages and ensures compliance with all reporting requirements, including annual and periodic reports Maintains knowledge of relevant evolving regulation and guidance Global Regulatory Teams - key contributor to establish and implement regulatory strategy GDT - ad hoc member Represents Sarepta as direct contact for FDA and at global health authority meetings including assisting planning, preparation for and conduct of meetings with Regulatory agencies for all assigned products Interacts across levels and line functions to lead team through successful engagements with Health Authorities More about You Experience with preparing INDs, IMPDs, NDA and/or MAA submission(s) is essential. This is a hands-on role requiring strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions. RAC certification recommended BS or equivalent with 10+ years of related experience What Now? We're always looking for solution-oriented, critical thinkers. So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply. #LI-Hybrid Blank This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $156,000 - $195,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. Candidates must be authorized to work in the U.S. Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.