FDA Regulation Associate Attorney

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.

This Vault Law 100 and one of the Best Law Firm in the Emerging Companies & Venture Capital firm boasts cutting-edge clients, pleasant people, and a flexible work/life balance. The firm is a global player with very deep tech roots and has been ranked among the top 10 M&A advisors in the nation. As the premier provider of legal services to technology, life sciences, and growth enterprises worldwide, the firm is appealing to associates for fostering an entrepreneurial and collaborative environment across its attorney ranks, emphasizing the importance of mentorship, career growth, and building leadership and relationship skills with clients and colleagues. Compensation at this firm is competitive with peer firms in the region.