Senior Manager, Regulatory Affairs

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

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
• 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 communica