Senior FDA Drug/Biologics Regulation Counsel

9-20 yrs required

Full-time

No

A law firm is seeking a Senior FDA Drug/Biologics Regulation Counsel to join their team in Washington, DC. The ideal candidate will provide comprehensive legal counsel on FDA regulation matters pertaining to drugs, biologics, cellular, and gene therapy products. Additionally, they will support corporate teams in various transactions and collaborate with patent teams on overlapping regulatory and patent strategy issues.

Duties:

• Provide expert legal counsel on FDA regulation matters related to drugs, biologics, cellular, and gene therapy products
• Support corporate teams in mergers and acquisitions (M&As), asset deals, initial public offerings (IPOs), and other complex transactions
• Collaborate with patent teams to address regulatory aspects that intersect with patent strategy

Requirements:

• Juris Doctor (JD) degree from an accredited law school
• Admission to the State Bar or eligibility for in-house counsel registration
• 10+ years of industry experience in drug/biologics development and FDA regulation
• Deep expertise in FDA regulation of drugs, biologics, cellular, and gene therapy products
• Proven track record of providing strategic legal counsel in a law firm or corporate setting

Skills:

• Strong understanding of FDA regulations and guidelines pertaining to drugs, biologics, cellular, and gene therapy products
• Excellent analytical, research, and problem-solving skills
• Effective communication and negotiation abilities
• Ability to work collaboratively in a team environment
• Attention to detail and ability to manage multiple tasks simultaneously
• Demonstrated ability to provide practical and strategic legal advice to clients

Legal