Regulatory Affairs CMC Co-op

Sarepta Therapeutics
United States, Massachusetts, Cambridge
215 First Street (Show on map)
Mar 25, 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. The Importance of the Role The Global Regulatory Affairs Chemistry, Manufacturing and Control (GRA-CMC) co-opportunity provides students with an overview of Regulatory Affairs (RA) responsibilities including general knowledge of global health authority requirements and guidance to develop regulatory CMC strategies to enable the development and/or lifecycle management of pharmaceutical products. The co-op will receive hands-on experience in developing the skills to prepare various global regulatory CMC submission documents for products in drug development and lifecycle (commercial) space, all while being an active contributor to the GRA-CMC Team. In addition, the co-op will have a unique networking opportunity to manage their own project by working in cross-functional teams outside of GRA-CMC as part of this comprehensive training and immersion program. The Opportunity to Make a Difference This application is for a 6-month co-op program that will start on July 7th, 2025, and conclude on December 19th, 2025. This is a full-time, 40 hours a week, co-op program. Support projects including change control regulatory assessments, and maintenance of regulatory tracking activities in the Veeva systems. Provide regulatory submission support for assigned products. Ensures documentation management and record keeping are compliant with regulatory expectations and Sarepta Standard Operating Procedures (SOPs). Develops and maintains knowledge of relevant evolving regulation and guidance. More about You Graduate student pursuing a degree in Regulatory Affairs. An undergraduate degree in science, technology, or engineering is preferable. Fundamental understanding of drug development shown by theoretical experience. Knowledge of current Food and Drug Administration (FDA) regulations, and guidelines, is desired. Proven leadership capabilities in an organizational setting (campus/community or employment activities) is desired. Able to work independently and be part of a group with curiosity and flexibility. 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-MC1 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 $22 - $34 per hour depending upon years of education completed and nature of role. 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.