Assistant General Counsel - FDA Regulatory & Commercial
Posted 3 weeks ago
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Provide collaborative legal advice and counsel for the commercialization of Regeneron's products within the Regulatory and Commercial Law team. Serve as a strategic legal advisor to internal collaborators including commercial, medical affairs, and regulatory teams, focusing on FDA regulatory and commercial matters.
Responsibilities
- Provide day-to-day strategic and business-focused legal and risk counseling for Regeneron's products/product candidates
- Advise on a broad range of healthcare regulatory matters, including labeling discussions, advertising/promotion, drug safety, and scientific exchange
- Demonstrate a solid understanding of client teams' strategic and tactical objectives; advise on brand and medical planning
- Counsel on all aspects of product commercialization, including launch preparation, market development, and strategic brand planning
- Ensure compliance with all relevant laws, regulations, policies, and procedures within supported business areas
- Advise on data disclosures following clinical development milestones via press releases and medical congresses
- Liaise with other Law Department functions (litigation, IP, Compliance, Transactions) for integrated legal support
Requirements
- JD with excellent law school credentials
- Licensed to practice law in New York or eligible for licensure as a registered in-house counsel
- 10+ years of legal experience as an in-house attorney at a biotech/pharmaceutical company
- 10+ years of legal experience at a nationally recognized law practice in pharmaceutical and healthcare law
- Ability to handle multiple priorities in a dynamic and evolving environment
- Excellent oral and written communication skills
- Proven capacity to cultivate strong client relationships and influence leadership
- Strong analytical skills and demonstrated learning agility
- Deep aptitude for science and data analysis
Qualifications
- JD with excellent law school credentials
- 10+ years of legal experience, including positions as an in-house attorney at a biotech/pharmaceutical company and at a nationally recognized law practice in pharmaceutical and healthcare law
Nice to Have
- Previous experience as a product attorney at a pharmaceutical or biotechnology company
Benefits
About BioSpace
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, specializing in discovering and bringing life-changing medicines to patients worldwide. They are investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, NC, focusing on parenteral medication...