Senior Regulatory Counsel — Global GxP & Gov't

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

Job summary

Flagship Pioneering is seeking a Director/Senior Director, Regulatory Counsel to lead regulatory efforts across government contracting, GxP, consumer/digital health, and medical device matters. You will shape regulatory strategy for Flagship's portfolio and support international expansion.

The role sits in Cambridge, MA, with an in-person work structure, reporting to the Legal team. A JD, bar admission, and 6–10 years of regulatory experience are required.

Qualifications

• J.D. from an accredited law school.
• Bar admission in at least one U.S. state and in good standing.
• 6–10 years in regulatory law with experience in government contracting regulation (FAR/DFARS) and life sciences (GxP, FDA).
• Experience advising on Consumer/Digital Health and/or medical device regulatory matters.
• International regulatory strategy experience, esp. China/Australia, is a plus.
• Experience in a law firm or in-house and ability to manage outside counsel.

Responsibilities

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

Skills

Regulatory frameworks

Regulatory guidance

Negotiation

Drafting

Outside counsel management

Communication

AI legal tools

Regulatory decision-making

Regulatory strategy

GxP/FDA experience

Education

Juris Doctor (J.D.)

Bar admission in at least one U.S. state

Tools

AI legal tools

Job description

Flagship Pioneering is seeking a Director/Senior Director, Regulatory Counsel to lead regulatory efforts across government contracting, GxP, consumer/digital health, and medical device matters. You will shape regulatory strategy for Flagship's portfolio and support international expansion.

The role sits in Cambridge, MA, with an in-person work structure, reporting to the Legal team. A JD, bar admission, and 6–10 years of regulatory experience are required.