FDA Regulation Associate Attorney

Profile

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.

Company info

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