FDA Regulation Associate Attorney

2-14 yrs required

Full-time

No

A law firm in San Francisco is seeking an FDA Regulation Associate Attorney with 5-10 years of broad experience in counseling companies with FDA-regulated products. The successful candidate will be responsible for reviewing contracts and supporting corporate deals involving regulated companies.

Duties:

• Provide legal counsel and guidance to clients on FDA regulatory compliance matters related to regulated products.
• Review contracts, agreements, and other legal documents for compliance with FDA regulations and guidelines.
• Assist in structuring and negotiating corporate transactions involving companies with FDA-regulated products.
• Conduct legal research on FDA regulations, policies, and guidance documents.
• Advise clients on labeling, advertising, and promotional activities for FDA-regulated products.
• Stay updated on developments in FDA regulations and industry trends affecting regulated products.
• Collaborate with cross-functional teams, including regulatory affairs, quality assurance, and marketing departments.

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 counseling companies with FDA-regulated products.
• Strong understanding of FDA regulations governing drugs, medical devices, biologics, or other regulated products.
• Experience reviewing contracts and supporting corporate transactions 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 guidance documents.
• Strong legal research and writing skills.
• Ability to review contracts and assess compliance with FDA regulations.
• Experience supporting corporate transactions involving regulated companies.
• Effective communication and interpersonal skills.
• Attention to detail and ability to manage multiple priorities.

Legal