Vice President, Chief U.S. Regulatory Counsel & Chief Compliance Officer

Sarepta Therapeutics•Cambridge, MA

2d•Hybrid

About The Position

The Vice President, Chief U.S. Regulatory Counsel & Chief Compliance Officer is responsible for providing regulatory and commercialization legal support, advice, and counsel in connection with planning, tactics, and strategies in the U.S. undertaken primarily by the Regulatory and Commercial departments of the Company. This role also will be responsible for leading our global compliance program, as well as partnering closely with our Head of Legal International on ex-U.S. regulatory and commercialization activities

Requirements

Juris Doctor with 15-20 years of progressive legal experience, including senior in-house leadership within the biotechnology or pharmaceutical industry supporting marketed products.
Deep expertise in the U.S. regulatory requirements applicable to a commercial-stage life sciences company, including with a focus in healthcare and FDA regulatory requirements.
Proven executive presence with the ability to influence senior leaders and navigate high stakes, highly regulated business decisions.
Strong judgment, integrity, and credibility as a visible leader responsible for enforcing Company policies and ethical standards.
Demonstrated ability to balance legal risk with business priorities in a public company context.
Highly organized, resilient leader capable of managing multiple priorities under pressure.
Self-directed, collaborative, and committed to the highest professional standards.

Responsibilities

Serve as principal advisor to the Executive Team on compliance, regulatory, and commercialization risk, providing clear, pragmatic, risk‑based guidance aligned with corporate strategy and public‑company expectations.
Lead the design, execution, and continuous evolution of Sarepta’s global compliance program, ensuring adherence to applicable federal, state, and international healthcare laws, regulations, and industry codes.
Set and steward the Company’s legal and compliance strategy for ethical promotion, medical engagement, and patient advocacy, proactively reducing enforcement, investigation, and reputational risk.
Provide executive oversight of Sales, Marketing, Commercial Operations, Medical Affairs, and Patient Advocacy activities, ensuring compliant execution across all commercial and medical engagement models.
Serve as a senior decision‑maker on cross‑functional promotional, medical, and commercialization review committees, with accountability for legal and compliance risk assessment, escalation, and mitigation.
Own monitoring, interpretation, and executive‑level communication of regulatory and enforcement developments impacting marketed pharmaceutical products, including FDA, OIG, DOJ, and related federal and state trends.
Lead Compliance Committee governance and Board‑level reporting, delivering clear insight into enterprise risk, program effectiveness, and emerging regulatory exposure to support informed oversight.
Provide executive‑level legal review and support negotiation of high-risk and strategic commercial agreements, including consulting, speaker, advisory board, and key vendor arrangements.
Lead Compliance Program to establish, maintain, and evolve Company policies, standards, and guardrails using a practical, risk‑based approach that supports business agility, scalability, and consistency while maintaining audit readiness and regulatory defensibility.
Build, lead, and mentor a high‑performing compliance and regulatory legal organization, fostering accountability, professional development, and consistent application of legal and ethical standards.