Senior FDA Drug/Biologics Regulation Counsel

Profile

A law firm is seeking a Senior FDA Drug/Biologics Regulation Counsel for its San Diego office. This role will primarily focus on providing legal counsel regarding FDA regulations pertaining to drugs, biologics, cellular and gene therapy products. The successful candidate will also support corporate teams in various transactions and patent teams where FDA regulation intersects with patent strategy.

Duties:

• Provide legal counsel on FDA regulations related to drugs, biologics, cellular, and gene therapy products.
• Support corporate teams in mergers and acquisitions (M&A), asset deals, initial public offerings (IPOs), and other complex transactions.
• Collaborate with patent teams to address areas where FDA regulation overlaps with patent strategy.

Requirements:

• Juris Doctor (JD) degree from an accredited law school.
• Admission to the State Bar in good standing.
• 10+ years of industry experience in drug/biologics development.
• In-depth understanding of FDA regulations governing drugs, biologics, cellular, and gene therapy products.
• Proven track record of providing legal counsel in highly regulated environments.

Education:

Juris Doctor (JD) degree from an accredited law school.

Certifications:

Admission to the State Bar in good standing.

Skills:

• Excellent understanding of FDA regulations and regulatory processes.
• Strong analytical and problem-solving skills.
• Ability to communicate complex legal concepts effectively.
• Proficiency in drafting legal documents and agreements.
• Experience collaborating with cross-functional teams.
• Attention to detail and ability to manage multiple tasks simultaneously.

Company info

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