Associate Director - Global Regulatory Strategy

Sarepta Therapeutics
United States, Massachusetts, Cambridge
215 First Street (Show on map)
Feb 19, 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 Works with the as Global Regulatory Leads (GRLs) to develop and implement regulatory strategies that align with the development and support specific activities of a commercial plans for a gene therapy product. Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Represents Regulatory at the Global Development Team with relevant line function leaders. Develops and delivers on fit for purpose high quality documentation (e.g. INDs, CTAs, NDAs, reports, and correspondences) to support successful global Health Authority interactions. Facilitates risk identification & mitigation strategies. Manages contractual and budgetary responsibilities with best business practices. The Opportunity to Make a Difference Develops fit-for-purpose regulatory strategies incorporating the totality of development (clinical, nonclinical, and CMC) and driving engagements that result in high-value feedback from global health authorities and support corporate objectives. Provides leadership for all meetings and communications, representing Sarepta as the direct contact for FDA and at global health authority meetings, including planning, preparation, and conduct of meetings with regulatory agencies for all assigned products. Interacts across the Regulatory department and other line functions to lead the team through successful engagements with regulatory agencies. In collaboration with the Regulatory project lead, responds to regulatory agency contacts (telephone, written, meetings, etc.) to ensure expedient and efficient review and approval of products. Ensures that all documents submitted to regulatory agencies are complete, well-organized, scientifically accurate, of high quality, in regulatory compliance, and presented in a way that facilitates agency review. Guides clinical and nonclinical study teams to implement appropriate regulatory strategies. Coordinates and manages regulatory activities required for submissions to regulatory agencies for assigned products. Maintains knowledge of relevant evolving regulations and guidance. Leads the Global Regulatory Teams to establish and implement a multi-disciplinary regulatory strategy. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company Works on objectives that have critical impact on functional area and the organization Establishes and assures adherence to budgets, schedules, work plans, and performance requirements Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities Expected to present and contribute to presentations at governance committees including Research and development Committee, the Executive Committee, and the Communications Committee More about You Knowledge of clinical and nonclinical data requirements for product labeling Demonstrated knowledge of drug development process. Knowledge of laws andregulations affecting the pharmaceutical industry, and regulatory experience. Experience with preparing regulatory submissions and briefing packages for regulatory meetings Personal leadership, with an ability to bring divergent views together, agree on common objectives and engenders enthusiasm even in challenging circumstances. Leading without authority Able to effectively communicate on regulatory topics both internally and externally Shows flexibility and is open to adaptable to change BS or equivalent with 10+ years of related experience Prior regulatory affairs experience in major markets is expected 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 #LI-CM1 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.