FDA Regulation Associate Attorney

2-14 yrs required

Full-time

No

A law firm in Palo Alto is seeking an experienced FDA Regulation Associate Attorney to join their team. The ideal candidate will have 5-10 years of broad experience counseling companies with FDA-regulated products, reviewing contracts, and supporting corporate deals involving regulated companies.

Duties:

• Provide legal counsel and guidance to clients on FDA regulatory matters related to regulated products.
• Review and analyze contracts, agreements, and other legal documents pertaining to FDA-regulated products.
• Assist in structuring and negotiating corporate transactions involving regulated companies, including mergers, acquisitions, and partnerships.
• Conduct legal research and analysis to ensure compliance with FDA regulations and industry standards.
• Advise clients on regulatory requirements for product development, approval, and marketing.
• Prepare and submit regulatory filings and responses to FDA inquiries on behalf of clients.
• Stay updated on changes in FDA regulations, guidelines, and policies to provide proactive legal advice.

Requirements:

• Juris Doctor (JD) degree from an accredited law school.
• Admission to the State Bar and eligibility to practice law.
• 5-10 years of experience in FDA regulatory law, preferably with a focus on counseling companies with FDA-regulated products.
• Strong understanding of FDA regulations governing product development, approval, and marketing.
• Experience reviewing contracts and supporting corporate deals involving regulated companies.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Skills:

• In-depth knowledge of FDA regulations and regulatory processes.
• Strong legal research and writing skills.
• Ability to analyze complex legal issues and provide practical solutions.
• Excellent communication and negotiation abilities.
• Attention to detail and ability to manage multiple tasks effectively.
• Team player with a client-focused approach to legal practice.

Legal