FDA Regulation Associate Attorney

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

Duties:

• Provide legal advice and guidance to clients on FDA regulatory requirements for products regulated by the FDA.
• Review contracts, agreements, and other legal documents to ensure compliance with FDA regulations.
• Conduct legal research on FDA regulations, guidance documents, and enforcement actions.
• Assist in the preparation and submission of regulatory filings to the FDA, including INDs, BLAs, and NDAs.
• Advise clients on FDA enforcement actions, warning letters, and product recalls.
• Support corporate transactions involving FDA-regulated companies, including mergers, acquisitions, and licensing agreements.
• Stay updated on developments in FDA regulations and industry trends to provide proactive legal counsel.

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, including experience with regulatory filings and enforcement actions.
• Experience reviewing contracts and supporting corporate transactions involving FDA-regulated companies.
• Excellent communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively within a team environment.

Skills:

• In-depth knowledge of FDA regulations and regulatory processes.
• Strong legal research and writing skills.
• Ability to review contracts and identify regulatory issues.
• Effective communication and negotiation abilities.
• Attention to detail and ability to manage multiple priorities effectively.
• Team player with the ability to collaborate with diverse stakeholders.

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.