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Job Details

FDA Regulation Associate Attorney

Company name
BCG Attorney Search

Experience
2-17 yrs required

Location
San Diego, CA, United States

Industry
Legal

Posted on
Jun 18, 2024

Valid Through
Jul 18, 2024

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

BCG Attorney Search

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