FDA Regulation Associate Attorney

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.

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.