Vice President, Chief U.S. Regulatory Counsel & Chief Compliance Officer
Cambridge, MA - USA
Job Summary
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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were 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: Importance of the Role
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 activitiesThe Opportunity to Make a Difference
Regulatory & Compliance Leadership
Serve as principal advisor to the Executive Team on compliance regulatory and commercialization risk providing clear pragmatic riskbased guidance aligned with corporate strategy and publiccompany expectations.
Lead the design execution and continuous evolution of Sareptas global compliance program ensuring adherence to applicable federal state and international healthcare laws regulations and industry codes.
Set and steward the Companys 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 decisionmaker on crossfunctional promotional medical and commercialization review committees with accountability for legal and compliance risk assessment escalation and mitigation.
Own monitoring interpretation and executivelevel 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 Boardlevel reporting delivering clear insight into enterprise risk program effectiveness and emerging regulatory exposure to support informed oversight.
Provide executivelevel legal review and support negotiation of highrisk 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 riskbased approach that supports business agility scalability and consistency while maintaining audit readiness and regulatory defensibility.
Build lead and mentor a highperforming compliance and regulatory legal organization fostering accountability professional development and consistent application of legal and ethical standards.
More about You
Juris Doctor with15-20years of progressive legal experience includingseniorin-houseleadership within the biotechnology or pharmaceutical industry supporting marketed products.
DeepexpertiseintheU.S. regulatoryrequirements applicable to a commercial-stagelife sciences company including with a focusinhealthcare and FDA regulatory requirements.
Proven executive presence with the ability to influence senior leaders and navigatehigh 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 apublic companycontext.
Highly organized resilientleadercapable of managing multiple priorities under pressure.
Self-directed collaborative and committed to the highest professional standards.
What Now
Were always looking for solution-oriented critical thinkers.
So if youre 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.
Required Experience:
Chief
About Company
We are focused on the development of precision genetic medicines to treat rare neuromuscular and central nervous system diseases. Learn more about Sarepta.