We are seeking a Corporate Counsel (or Senior Corporate Counsel, depending on experience) to join the Products/Regulatory Law Group. The position will provide proactive and collaborative regulatory law support for a wide range of internal clients, including marketing, sales, medical, market access, regulatory, and compliance. The position requires a deep understanding of and experience with healthcare laws, including the Food, Drug and Cosmetic Act, the False Claims Act, Anti-Kickback laws, as well as knowledge of market access strategies and patient support programs. The ideal candidate will have in-house experience counseling on an approved product and delivering practical and strategic legal advice on a broad range of issues.
Responsibilities • Provides product support counseling for one or more products/product candidates, from development through commercialization and lifecycle planning: o Counsels on launch preparation activities for product candidates o Advises on brand-related strategic planning and business operating plans o Reviews and approves promotional materials o Advises on FDA regulatory submissions and labeling negotiations o Reviews and approves medical materials and publications o Provides day-to-day client counseling on advertising and promotion, privacy, drug safety, market research, scientific exchange, interactions with healthcare professionals, sponsorships, and grants • Provides legal advice on market access matters across the product portfolio, including managed care contracting, specialty pharmacy contracting, healthcare coverage and reimbursement issues, patient support programs, government price reporting etc. • Assists with a broad range of other healthcare regulatory matters including privacy, interactions/contracts with healthcare professionals and patients, patient advocacy, legal counsel to Compliance, reviewing and drafting contracts, and policy development.
JD licensed to practice law in New York or be eligible for licensure as a registered in-house counsel • 8 plus years relevant legal experience. Prior in-house pharmaceutical and/or biotech experience preferred. • Deep knowledge of healthcare laws and life sciences regulatory enforcement trends, including market access/managed care matters • Exceptional oral and written communication skills, including the ability to communicate clearly and deliver integrated and balanced legal advice • Excellent intrapersonal skills and ability to work in a collaborative, team-oriented environment • Ability to maintain an independent and objective perspective while developing and maintaining strong client relationships • History of self-motivation, meeting aggressive deadlines, and demonstrated success working in high performing and results driven environment.
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in ...development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.