Associate Director, GRA

About the role

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. 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.

Responsibilities

• Works as Global Regulatory Leads (GRLs). 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.
• Oversees activities of junior regulatory personnel.
• Manages contractual and budgetary responsibilities with best business practices.
• Develops fit for purpose regulatory strategies incorporating totality of development (clinical, nonclinical, and CMC) and driving engagements that result in high value feedback from global health authorities and support Corporate objectives.
• Represents Sarepta as direct contact for FDA and at global health authority meetings including a planning, preparation for and conduct of meetings with Regulatory agencies for all assigned products.
• Interacts across the Regulatory department and other line functions to lead team through successful engagements with Regulatory Agencies.
• In collaboration with Regulatory project lead, responds to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products.
• Ensures that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, and scientifically accurate, of high quality, are in regulatory compliance, and are 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 regulation and guidance.
• Global Regulatory Teams - lead team to establish and implement multi-disciplinary regulatory strategy.

Requirements

• 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.
• Candidates must be authorized to work in the U.S.

Qualifications

• BS or equivalent with 10+ years of related experience.
• Prior regulatory affairs experience in major markets is expected.

Skills

• Knowledge of clinical and nonclinical data