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 in San Francisco to join their team. The Senior FDA Drug/Biologics Regulation Counsel will play a pivotal role in providing legal counsel and strategic guidance on FDA regulations pertaining to drug, biologics, cellular, and gene therapy products. They will support corporate teams in various complex transactions, including M&As, asset deals, IPOs, and provide valuable insights to patent teams on areas where FDA regulations intersect with patent strategy.

Duties:

• Provide expert legal advice and guidance on FDA regulations governing drug, biologics, cellular, and gene therapy products.
• Advise on compliance with FDA requirements throughout the product lifecycle, from development to post-market activities.
• Conduct legal research and analysis on emerging FDA regulations and industry trends.
• Draft and review regulatory submissions, including INDs, BLAs, and NDAs.
• Collaborate with cross-functional teams to ensure alignment with regulatory strategies.
• Represent clients in interactions with regulatory agencies, including FDA meetings and inspections.
• Develop and deliver training programs on FDA regulations and compliance best practices.

Requirements:

• Juris Doctor (JD) degree from an accredited law school.
• Admission to the Bar in at least one state, preferably California.
• 10+ years of relevant experience in drug/biologics development and FDA regulation.
• Proven track record of providing strategic legal counsel in a law firm or corporate setting.
• Deep understanding of FDA regulations and industry standards pertaining to drug, biologics, cellular, and gene therapy products.
• Strong analytical and problem-solving skills with the ability to navigate complex regulatory issues.
• Excellent communication and negotiation skills, with the ability to interact effectively with clients and regulatory agencies.

Education:

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

Certifications:

Admission to the Bar in at least one state, preferably California.

Skills:

• Expertise in FDA regulations governing drug, biologics, cellular, and gene therapy products.
• Legal research and analytical skills.
• Regulatory submission drafting and review.
• Strategic planning and decision-making.
• Cross-functional collaboration and communication.

Legal