Regulatory Counsel, Global Health & Life Sciences

Flagship Pioneering, Inc.; Cambridge (MA); On-site; USD 172,000 - 281,000; Full time

Benefits offered by this job

Healthcare coverage

Annual incentive program

Retirement benefits

Job summary

Flagship Pioneering in Cambridge, MA seeks a Regulatory Counsel to lead regulatory efforts across government contracting obligations and GxP matters supporting a diverse portfolio, including medical devices, consumer health, and digital health initiatives. This cross-platform mandate shapes regulatory strategy across the company's portfolio.

The role collaborates with Compliance, supports international expansion, and requires a J.D., bar admission, 6–10 years in regulatory law with FAR/DFARS and

Qualifications

• Juris Doctor degree from an accredited law school.
• Bar admission in at least one U.S. state in good standing.
• 6–10 years of regulatory law experience, including government contracting (FAR/DFARS) and life sciences (GxP/FDA).

Responsibilities

• Lead regulatory efforts tied to government contracting obligations, partnering with Compliance.
• Embed practical regulatory guidance supporting GxP compliance and growth initiatives.
• Advise Consumer and Digital Health and medical device regulatory matters.
• Support international expansion and regulatory strategies in priority markets.
• Accelerate regulatory decision-making across the organization.
• Monitor regulatory developments and advise leadership on risks and requirements.
• Partner with the Compliance Manager to build in-house regulatory capability.

Skills

Regulatory expertise

Regulatory guidance

Negotiation & drafting

Communication skills

Outside counsel mgmt

AI tools awareness

Education

J.D.

Bar admission

Job description

Flagship Pioneering in Cambridge, MA seeks a Regulatory Counsel to lead regulatory efforts across government contracting obligations and GxP matters supporting a diverse portfolio, including medical devices, consumer health, and digital health initiatives. This cross-platform mandate shapes regulatory strategy across the company's portfolio.

The role collaborates with Compliance, supports international expansion, and requires a J.D., bar admission, 6–10 years in regulatory law with FAR/DFARS and