Associate Director, GRA

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.

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

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

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

Desired Education and Skills:

Skills and Competencies

Knowledge of clinical and nonclinical data requirements for product labeling

Demonstrated knowledge of drug development process. Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.

Experience with preparing regulatory submissions and briefing packages for regulatory meetings

Personal leadership, with an ability to bring divergent views together, agree on common objectives and engenders enthusiasm even in challenging circumstances. Leading without authority

Able to effectively communicate on regulatory topics both internally and externally

Shows flexibility and is open to adaptable to change

Education and Experience

BS or equivalent with 10+ years of related experience

Prior regulatory affairs experience in major markets is expected

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.