Senior Regulatory Counsel — Global Biotech & Health

Flagship Pioneering; Cambridge (MA); Vor Ort; USD 172.000 - 281.000; Vollzeit

Zusammenfassung

Flagship Pioneering is seeking a Regulatory Counsel in Cambridge, MA to lead regulatory efforts across government contracting and life sciences. This role shapes regulatory strategy for Flagship's emerging technologies and supports international expansion with a proactive, professional approach.

The ideal candidate brings 6–10 years of regulatory law experience, Juris Doctor, and U.S. bar admission, with strong skills in translating complex rules into actionable guidance for scientific teams.

Qualifikationen

• J.D. degree from an accredited law school.
• Bar admission in at least one U.S. state and in good standing.

Aufgaben

• Lead regulatory efforts tied to government contracting obligations, partnering with Flagship’s Compliance group.
• Embed practical, business‑oriented regulatory guidance supporting GxP compliance and product growth initiatives.
• Advise Consumer and Digital Health initiatives and provide regulatory guidance on medical device matters.
• Support international expansion efforts, including regulatory strategies in priority markets.
• Accelerate regulatory decision‑making across the organization.
• Monitor regulatory developments relevant to government contracting, GxP, Consumer/Digital Health, and medical device activities, and advise leadership on emerging risks and requirements.
• Partner with the Compliance Manager to build scalable, in‑house regulatory and compliance capability across the Flagship ecosystem.

Kenntnisse

Regulatory expertise

Regulatory strategy

Legal drafting

Negotiation

Regulatory compliance

Communication

AI tooling awareness

Ausbildung

J.D. degree

Bar admission

Jobbeschreibung

Flagship Pioneering is seeking a Regulatory Counsel in Cambridge, MA to lead regulatory efforts across government contracting and life sciences. This role shapes regulatory strategy for Flagship's emerging technologies and supports international expansion with a proactive, professional approach.

The ideal candidate brings 6–10 years of regulatory law experience, Juris Doctor, and U.S. bar admission, with strong skills in translating complex rules into actionable guidance for scientific teams.