Senior Legal Director, R&D and Regulatory Counsel
Core
Strategic legal leader enabling efficient decision-making on regulatory pathways, product development, and lifecycle management for novel modalities in life sciences.
Role type
Senior Legal Director, R&D and Regulatory Counsel
Builds
Regulatory strategy, clinical compliance frameworks, and legal solutions supporting pipeline delivery and portfolio growth.
Domain
Life Sciences / Biopharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
FDA regulatory law expertise, U.S. and global regulatory pathway knowledge, GCP compliance, contract negotiation, policy analysis, risk management
Preferred skills
EMA processes knowledge, government service experience
Technologies
None stated
Responsibilities
Provide legal counsel on regulatory pathways and product classification; Partner on public policy and government relations advocacy; Advise on GCP compliance, fraud prevention, and inspection readiness; Investigate allegations and manage legal reporting; Monitor evolving legislation and enforcement trends; Support complex research contract negotiations; Design integrated legal solutions for pipeline delivery; Develop scalable policies and governance tools.
Seniority
Senior, strategic leadership
