Senior Associate, Regulatory Strategy

Sarepta Therapeutics
United States, Massachusetts, Cambridge
215 First Street (Show on map)
Apr 07, 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 by providing Regulatory Strategy Operational Support to a variety of project teams. Responsible for completing and tracking of requested activities while in compliance of SOP timelines and/or timelines specified by RA leads. Actively supports RA project leads with Regulatory activities associated with the preparation and submission of agency questions, periodic submissions, INDs, NDAs and BLAs. Completion of work must be in compliance with SOPs and GRA best practices. The Opportunity to Make a Difference Ensures accurate planning & tracking of activities requested by various project teams Ensures completion of entries in internal regulatory systems, effective assembly and preparation of submission dossiers as requested With supervision, provides regulatory support for various products, including product lifecycle With supervision supports submission owner on preparation of submission core content Ensures effective co-ordination of the review & approval of submission documents, as required to ensure regulatory compliance More about You BS or equivalent with 3-6 years of relevant experience Works on issues where analysis of situations or data requires evaluation of a variety of factors and an understanding of current business trends Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Follows the advice of more senior team members to resolve technical and planning problems Works on objectives that support department goals rather than as a key contributor to corporate goals Erroneous decisions or failure to execute has medium impact to overall GRA deliverables Excellent organizational, tracking of tasks and planning ability Ability to clearly convey information to peers, supervisors and other internal stakeholders using written and verbal (English) Good presentation and negotiation skills, the ability to influence others without authority Knowledge of global pharmaceutical regulations and guidelines Experience supporting and working with cross functional project teams Proficient in Microsoft Office Suite (Outlook, Word, etc.) and Adobe Acrobat Ability to quickly become proficient with internal regulatory systems 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 $92,000 - $115,000 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.