Senior FDA Drug/Biologics Regulation Counsel

A law firm based in Palo Alto is seeking a highly experienced Senior FDA Drug/Biologics Regulation Counsel to provide comprehensive legal support in FDA regulatory matters pertaining to drug and biologics development. The successful candidate will also collaborate with corporate teams in mergers and acquisitions, asset deals, IPOs, and other complex transactions, as well as with patent teams to navigate areas where FDA regulation intersects with patent strategy.

Duties:

• Provide expert legal advice and guidance on FDA regulatory requirements and compliance for drug, biologics, cellular, and gene therapy products.
• Analyze and interpret FDA regulations, guidelines, and policies to ensure client adherence and mitigate regulatory risks.
• Assist in the preparation and submission of regulatory filings, including INDs, BLAs, NDAs, and other relevant applications.
• Conduct due diligence reviews for corporate transactions involving FDA-regulated products.
• Collaborate with patent teams to align FDA regulatory strategies with patent protection efforts.
• Stay abreast of developments in FDA regulations, industry trends, and best practices to provide proactive legal counsel.

Requirements:

• Juris Doctor (JD) degree from an accredited law school.
• Admission to the State Bar and eligibility to practice law.
• Minimum of 10 years of industry experience in drug and biologics development, with a focus on FDA regulatory matters.
• Deep understanding of FDA regulations governing drugs, biologics, cellular, and gene therapy products.
• Proven track record of providing strategic legal advice in complex regulatory environments.
• Experience in supporting corporate transactions, such as mergers, acquisitions, asset deals, and IPOs, preferred.
• Strong analytical, problem-solving, and communication skills.

Skills:

• In-depth knowledge of FDA regulations pertaining to drug and biologics development.
• Strong legal research and analytical skills.
• Excellent communication and interpersonal abilities.
• Ability to work collaboratively in cross-functional teams.
• Proven ability to provide strategic legal counsel and mitigate regulatory risks.

This Vault Law 100 and one of the Best Law Firm in the Emerging Companies & Venture Capital firm boasts cutting-edge clients, pleasant people, and a flexible work/life balance. The firm is a global player with very deep tech roots and has been ranked among the top 10 M&A advisors in the nation. As the premier provider of legal services to technology, life sciences, and growth enterprises worldwide, the firm is appealing to associates for fostering an entrepreneurial and collaborative environment across its attorney ranks, emphasizing the importance of mentorship, career growth, and building leadership and relationship skills with clients and colleagues. Compensation at this firm is competitive with peer firms in the region.