Director/Senior Director, Regulatory Counsel
Core
Lead regulatory efforts for government contracting obligations and advise on GxP, Consumer, Digital Health, and Medical Device matters across Flagship's portfolio.
Role type
Senior in-house regulatory counsel (government contracting & life sciences)
Builds
Regulatory strategy and compliance frameworks for emerging biotech and health technologies
Domain
Life Sciences / Biotechnology / Government Contracting
Deliverable
client delivery
Required skills
Regulatory law expertise, Government contracting (FAR/DFARS), Life sciences regulation (GxP/FDA), International regulatory strategy, Outside counsel management, Risk assessment
Preferred skills
Consumer/Digital Health regulation, Medical device regulation, China/Australia market experience
Technologies
AI legal tools
Responsibilities
Lead regulatory efforts tied to government contracting obligations, Embed practical regulatory guidance supporting GxP compliance, Advise on Consumer and Digital Health initiatives and medical device matters, Support international expansion efforts including clinical-development strategies, Monitor regulatory developments and advise leadership on emerging risks, Partner with Compliance to build in-house regulatory capability
Seniority
Senior, hands-on IC
