Assistant General Counsel - FDA Regulatory & Commercial

Role Summary

This position with the Regeneron Regulatory and Commercial Law team provides proactive and collaborative legal advice and counsel in connection with the commercialization of Regeneron products. The role supports cardiovascular, hematology, rare disease, oncology, obesity, and new products, serving as a strategic legal advisor to internal stakeholders across commercial, medical affairs, regulatory, HEOR, corporate affairs, and compliance teams. The ideal candidate will have in-house experience counseling on an approved product and providing practical and strategic legal guidance on a broad range of issues. This role is based at Regeneron's Sleepy Hollow, NY offices (4 days onsite; not open to hybrid or fully remote).

Responsibilities

• Providing day-to-day strategic and business-focused legal and risk counseling for one or more Regeneron products/product candidates from development through commercialization, including regulatory labeling discussions, advertising and promotion, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients.
• Understanding client teams' strategic and tactical objectives and advising on strategic brand and medical planning, developing creative solutions aligned with business priorities and regulatory landscapes.
• Counseling on all aspects of product commercialization, including launch preparation/execution, market development, disease awareness, product communication, advertising and promotion, and strategic brand planning.
• Ensuring compliance with relevant laws, regulations, policies, procedures, and controls within supported business areas.
• Advising on data disclosures following clinical milestones via press releases and medical congresses/scientific exchanges in compliance with laws and regulations.
• Liaising with other Law Department functions in the US and globally to ensure integrated legal support and timely updates.
• Reviewing relevant draft scientific publications and providing guidance as appropriate.
• Providing additional legal support on various matters for the Regulatory and Commercialization Law Team.

Qualifications

• Previous experience as a product attorney at a pharmaceutical or biotechnology company preferred.
• Ability to handle multiple priorities in a dynamic environment.
• Excellent oral and written communication skills with the ability to present complex information clearly to influence stakeholders at all levels.
• Proven ability to cultivate client relationships and influence leadership, with the ability to assess and help business colleagues manage risks in a highly regulated environment.
• Strong analytical skills, learning agility, and a deep aptitude for science and data analysis.
• Commitment to teamwork and collaboration across multiple functional areas.

Education

• JD with excellent law school credentials; licensed to practice in New York or eligible for in-house counsel licensure. 10+ years of legal experience, including in-house biotech/pharma and at a national law practice in pharmaceutical and healthcare law. Deep knowledge of regulatory frameworks governing sale and marketing of biopharmaceuticals.