Associate Director, GRA

Sarepta Therapeutics; Cambridge (MA); On-site; USD 161,000 - 201,000; Full time

Job summary

Sarepta Therapeutics is seeking a Global Regulatory Lead to drive high quality regulatory documents (INDs, CTAs, NDAs) and lead interactions with Health Authorities for global programs. The role partners with cross-functional teams, manages junior staff, and oversees budgets.

Hybrid work on-site at Sarepta facilities in the United States is expected, with periodic international meetings. You will craft regulatory strategies, ensure compliance, and guide teams through FDA engagements, while

Qualifications

• Regulatory leadership experience in major markets.
• Experience preparing regulatory submissions and briefing packages.
• Ability to lead cross-functional teams and manage budgets.

Responsibilities

• Develop regulatory strategies across clinical, nonclinical, and CMC.
• Lead preparation of regulatory submissions (INDs, CTAs, NDAs) and agency meetings.
• Coordinate with global teams and manage regulatory project timelines.

Skills

Regulatory leadership

FDA regulations

Regulatory strategy

Cross-functional leadership

Education

BS or equivalent

Job description

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.

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

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.

The Opportunity to Make a Difference

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.

More about You

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.

What Now?

#LI-Hybrid 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.

The targeted salary range for this position is $160,800 - $201,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

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.

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 (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.