Legal Counsel (Commercial)

Role Overview: The Associate General Counsel leads the commercial legal function, supporting the first U.S. product launch and providing strategic, practical legal advice to commercial, medical, and patient support teams. Responsibilities: Serve as SME on healthcare laws, FDA regulations, and industry codes; advise on pre-launch, launch, and ongoing activities including marketing, medical affairs, market access, and patient support; oversee external counsel and review external content. Collaborate with Compliance to develop and maintain risk-based compliance programs, policies, and training. Qualifications & Skills: JD with 12+ years in biopharma or biotech; deep knowledge of FDA promotional rules, healthcare laws, and industry standards; experience with product launches, promotional review processes, and cross-functional collaboration. Strong communication, risk management, and adaptability in a fast-paced environment are essential.