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 for their Boston office. The candidate will provide comprehensive legal counsel and guidance on FDA regulations pertaining 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 intricate transactions.

Collaborate with patent teams to address areas where FDA regulations intersect with patent strategy.

Duties:

• Offer expert legal advice on FDA regulations governing drug/biologics development.
• Review and draft legal documents related to FDA compliance and regulatory submissions.
• Advise clients on compliance with FDA regulations throughout the drug/biologics development lifecycle.
• Conduct legal research and analysis on emerging FDA regulatory issues.
• Represent clients in FDA interactions, including meetings, submissions, and enforcement actions.
• Provide training and guidance to internal teams on FDA compliance matters.

Requirements:

• 10+ years of industry experience in drug/biologics development.
• In-depth knowledge of FDA regulations pertaining to drugs, biologics, cellular, and gene therapy products.
• Proven track record of providing legal counsel on FDA regulatory matters.
• Experience supporting corporate teams in complex transactions such as M&A, asset deals, and IPOs.
• Strong understanding of the intersection between FDA regulations and patent strategy.
• Excellent communication, negotiation, and problem-solving skills.

Education & Certifications:

• Juris Doctor (JD) degree from an accredited law school.
• Admission to the Bar in the relevant jurisdiction.
• Additional certifications in FDA law or regulatory affairs preferred.

Skills:

• Legal research and analysis.
• Regulatory compliance.
• Contract drafting and negotiation.
• Client counseling and communication.
• Team collaboration and leadership.

Legal