S
Not Specified Permanent

Cambridge, Massachusetts · USA job

Director/Senior Director, Regulatory Counsel

Seres Therapeutics

Cambridge, Massachusetts

Job description

Overview

As Regulatory Counsel at Flagship Pioneering, you will lead regulatory efforts tied to government contracting, support GxP and growth initiatives, and advise on Consumer, Digital Health, and Medical Device matters. You will shape regulatory strategy across Flagship's portfolio of emerging technologies and back international expansion with accelerated decision-making. This high-visibility role demands proactive, professional partnership with cross-functional teams to enable rapid, compliant progress in cutting-edge health and tech ventures. Your work will directly impact how we accelerate regulatory outcomes across diverse platforms.

Compensation / Benefits
  • $172,000 - $280,500 salary range
  • healthcare coverage
  • annual incentive program
  • retirement benefits
  • broad range of other benefits
Responsibilities
  • Lead regulatory efforts tied to government contracting obligations in partnership with Compliance
  • Embed practical regulatory guidance supporting GxP compliance and growth initiatives
  • Advise on Consumer and Digital Health initiatives and medical device matters
  • Support international expansion with clinical-development regulatory strategies in priority markets
  • Accelerate regulatory decision-making across the organization
  • Monitor regulatory developments and advise leadership on emerging risks and requirements
  • Partner with Compliance Manager to build scalable in-house regulatory and compliance capabilities across Flagship ecosystem
Key requirements
  • Juris Doctor (J.D.) from an accredited law school
  • Bar admission in at least one U.S. state and in good standing
  • 6-10 years of regulatory law experience with government contracting (FAR/DFARS) and life sciences (GxP, FDA)
  • Experience advising on Consumer/Digital Health and/or medical device regulatory matters (strongly preferred)
  • International regulatory strategy experience, especially in China, Australia, or other priority ex-U.S. markets (plus)
  • Experience in law firm or in-house setting with ability to manage outside counsel
  • Strong judgment and decision-making under fast-paced conditions
  • Excellent negotiation, drafting, and analytical abilities
  • Clear, actionable regulatory guidance for cross-functional teams
  • Regulatory frameworks for government contracting and life sciences
  • GxP regulatory knowledge (FDA)
  • FAR/DFARS government contracting

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