Senior FDA Drug/Biologics Regulation Counsel

Profile

A law firm in Seattle is seeking a highly experienced Senior FDA Drug/Biologics Regulation Counsel to provide expertise in FDA regulation of drugs, biologics, cellular, and gene therapy products. The ideal candidate will support corporate teams in various complex transactions and patent teams in areas where FDA regulation overlaps with patent strategy.

Duties:

• Provide comprehensive legal counsel on FDA regulations pertaining to drug, biologics, cellular, and gene therapy products.
• Collaborate with corporate teams in M&As, asset deals, IPOs, and other complex transactions, ensuring compliance with FDA regulations.
• Support patent teams in navigating FDA regulatory requirements relevant to patent strategy.
• Conduct legal research and analysis on emerging FDA regulations and guidance documents.
• Draft and review legal documents, including regulatory submissions, agreements, and compliance documentation.
• Advise clients on risk mitigation strategies related to FDA regulatory compliance.

Requirements:

• Juris Doctor (JD) degree from an accredited law school.
• Admission to the State Bar or eligibility for Registered In-House Counsel status.
• Minimum of 10 years of industry experience in drug/biologics development.
• Extensive expertise in FDA regulation of drugs, biologics, cellular, and gene therapy products.
• Proven track record of providing legal counsel to pharmaceutical or biotechnology companies.
• Strong understanding of complex transactions, including M&As, asset deals, and IPOs.

Education:

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

Certifications:

Admission to the State Bar or eligibility for Registered In-House Counsel status.

Skills:

• Exceptional understanding of FDA regulations and guidance documents related to drugs, biologics, cellular, and gene therapy products.
• Excellent legal research, writing, and analytical skills.
• Ability to collaborate effectively with cross-functional teams.
• Strong communication and negotiation skills.
• Detail-oriented with a commitment to accuracy and compliance.

Company info

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