Director/Senior Director, Regulatory Counsel

The role

The Regulatory Counsel will lead regulatory efforts for government contracting obligations and advise on GxP, Consumer, Digital Health, and Medical Device matters. This role shapes regulatory strategy across the entire portfolio of emerging technologies and supports international expansion.

What you will do

• Lead regulatory efforts tied to government contracting obligations.
• Provide business-oriented regulatory guidance supporting GxP compliance.
• Advise Consumer and Digital Health initiatives and medical device matters.
• Support international expansion efforts and clinical-development regulatory strategies.
• Accelerate regulatory decision-making across the organization.
• Monitor regulatory developments and advise leadership on emerging risks.
• Partner with the Compliance Manager to build in-house regulatory and compliance capability.

Required qualifications

• Juris Doctor (J.D.) degree from an accredited law school.
• Admitted to the bar in at least one U.S. state and in good standing.
• 6 to 10 years of professional experience in regulatory law.
• Substantial experience in government contracting regulation (e.g., FAR/DFARS).
• Substantial experience in life sciences regulatory matters (e.g., GxP, FDA).
• Experience working in a law firm or in-house legal department.
• Ability to manage outside counsel efficiently.
• Deep subject-matter expertise in regulatory frameworks for government contracting and/or life sciences.
• Ability to translate complex regulatory requirements into actionable guidance.
• Strong judgment and ability to make timely regulatory decisions.
• Excellent negotiation, drafting, and analytical skills.
• High level of responsiveness and exceptional interpersonal and communication skills.

Nice to have

• Experience advising on Consumer/Digital Health and/or medical device regulatory matters.
• Experience with international regulatory strategy, particularly in China, Australia, or other priority ex-U.S. markets.
• Willingness and enthusiasm to learn, evaluate, and apply state-of-the-art AI legal tools.

Benefits

• Healthcare coverage
• Annual incentive program
• Retirement benefits
• Broad range of other benefits

About the company

Flagship Pioneering is a scientific innovation engine that invents and builds companies that change the world. It unites life science innovation, company creation, and capital investment to create breakthroughs for people and planet.