Associate Director, Regulatory Affairs CMC

Sarepta Therapeutics
United States, Massachusetts, Cambridge
215 First Street (Show on map)
Mar 04, 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 Reporting to the Director, CMC this position will provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs for development and commercial gene therapy products. Lead submissions with minimal supervison for one or more RA CMC development and/or 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 CMC strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and in high quality. This position provides product regulatory CMC strategy and direction to Tech Ops, Quality, commercial and clinical teams internally and agency engagement and alliance partner interactions externally. The Opportunity to Make a Difference Serves as regulatory CMC lead or support 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, writes and reviews submission-ready CMC and marketing registration applications, supplements, amendments, and variations As the primary or supportive regulatory CMC representative member for assigned projects, provides CMC regulatory guidance for global development and registration programs (e.g. IND/IMPD/CTAs, NDA/BLA/MAAs). Attends internal meetings as well as regulatory agencies meetings Assesses and communicates CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines Manages the review, comments resolution and approval process to ensure ready for transfer to Reg Ops for subsequent activities Identifies areas to implement innovative regulatory strategies to support Sarepta's objectives Participates in Global Regulatory Teams Contributes to, with the ability to own, SOPs and internal regulatory quality procedures More about You Must thrive working in a fast-paced, innovative environment demonstrating flexibility and a proactive approach. Excellent interpersonal and negotiation skills with the ability to develop important relationships with key stakeholders. Ability to manage conflict and analyze complex issues to develop relevant and pragmatic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues to a broad audience. BS or equivalent with 10+ years of related experience. Experience with preparing INDs, IMPDs, BLA, NDA and/or MAA submission(s) is essential Hands-on role requiring strong knowledge and experience in the writing and the overall preparation of CMC sections of regulatory submissions Experience working in a matrix environment and excellent people skills RAC certification recommended Excellent interpersonal, collaboration, written, verbal and visual communication skills with ability to influence cross-functionally at all levels within the organization Solid sense of accountability, sound judgement, and strong attention to detail 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-Remote #LI-CM1 This position is remote. However, 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.