FDA Regulation Associate Attorney

2-14 yrs required

Full-time

No

A law firm in Boston is seeking an FDA Regulation Associate Attorney with 5-10 years of broad experience in counseling companies with FDA-regulated products. The ideal candidate will have experience reviewing contracts and supporting corporate deals involving regulated companies.

Duties:

• Provide legal advice and guidance to companies regarding FDA regulations pertaining to regulated products.
• Review and analyze contracts, agreements, and other legal documents related to FDA-regulated products and transactions.
• Assist in structuring and negotiating corporate deals involving FDA-regulated companies, including mergers, acquisitions, and licensing agreements.
• Conduct due diligence reviews for transactions involving FDA-regulated companies to ensure compliance and mitigate risks.
• Collaborate with cross-functional teams, including regulatory affairs, compliance, and business development, to address legal issues and achieve business objectives.
• Stay abreast of changes in FDA regulations, industry trends, and best practices to provide proactive legal counsel to clients.
• Represent clients in interactions with regulatory agencies and other relevant stakeholders.

Requirements:

• Juris Doctor (JD) degree from an accredited law school.
• Admission to the State Bar and eligibility to practice law in MA.
• 5-10 years of experience in counseling companies with FDA-regulated products.
• Strong understanding of FDA regulations governing regulated products, including drugs, medical devices, and biologics.
• Experience reviewing contracts and providing legal support for corporate deals involving regulated companies.
• Excellent analytical, problem-solving, and communication skills.
• Ability to work independently and collaboratively within a team environment.
• Demonstrated ability to manage multiple projects and prioritize tasks effectively.

Skills:

• In-depth knowledge of FDA regulations and regulatory requirements for regulated products.
• Strong contract review and negotiation skills.
• Excellent legal research and writing abilities.
• Effective communication and interpersonal skills.
• Ability to work under pressure and meet deadlines.
• Attention to detail and accuracy in legal work.

Legal