Senior Manager, CMC Regulatory

Job description

Why Sarepta? Why Now? Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne Muscular Dystrophy and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our next-generation siRNA platform is focused on chronically administered therapies for neurodegenerative and pulmonary diseases. 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 Lead or co-lead for one RA CMC development and/or marketed product and provide support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. Works closely with subject matter experts within CMC technical operations and QA working within a CMC sub-team structure and serving as a member of the GRT. Contributes to the development of fit for purpose high quality documentation (e.g., INDs, CTAs, NDAs, reports, and correspondences) to support global Health Authority interactions. May oversee activities of junior regulatory personnel. Builds/maintains relationships globally and cross-functionally to ensure effective communication & efficient implementation of regulatory activities for assigned programs. Applies and further develops knowledge of assigned market regulatory procedures. The Opportunity to Make a Difference Contributes to developing CMC regulatory strategies for assigned projects and programs while accurately interpreting and reflecting regulatory guidelines and corporate guidelines Coordinates the preparation and submission of documents to appropriate regulatory agencies for assigned projects and programs to implement regulatory strategy in line with corporate goals Responsible for completing change control regulatory assessments, maintenance of regulatory tracker and submission preparation activities. May lead CMC submissions and agency responses. Ensure documentation management and record keeping are compliant with regulatory expectations and Sarepta SOPs. Required to support preparation for inspection readiness Maintains/further develops knowledge of relevant evolving regulation and guidance Global Regulatory Teams –contributor to establish and implement regulatory strategy Impact and Scope: Works on issues where analysis of situations or data requires a knowledge of organizational objectives and current business trends Establishes and assures adherence to budgets, schedules, work plans, and performance requirements Works on objectives that have major impact on functional area and the organization Erroneous decisions may result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities. More about You Experience working in GRTs and cross functional teams Knowledge of drug development, ICH guidelines and regulatory process. Experience of IND/CTA, IMPDs, Orphan drug designation, Agency Advice, NDA and/or MAA submission Demonstrated experience with and a clear understanding of submission content and format requirements Ability to successfully manage projects/timelines, organize/track complex information & prioritize, by communicating with internal and external stakeholders Adaptive communication skills (including interpersonal, written, verbal) and able to influence others without authority Solid sense of accountability and sound judgement; highest ethical standards and focus on quality and details Ability to evaluate and recommend process improvement and suggest/implement best practices. RAC certification recommended Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems. BS or equivalent, 8+ years relevant 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 #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. 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.