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Associate Director, Corporate Counsel - Regulatory and Commercial
April 26, 2018
Tarrytown, New York
Full Time - Staff Attorney
5-7 years experience
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.
We are seeking a Corporate Counsel to join the Regulatory and Commercial Law Group. The position will provide will provide proactive and collaborative legal support in connection with one or more of Regeneron’s products and legal advice to a wide range of internal clients, including sales, commercial, medical affairs, regulatory, and compliance. The level of counseling requires a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to discovery, development and sales and marketing of biotechnology products (including healthcare fraud and abuse laws). The ideal candidate will have relevant in-house experience counseling on an approved product and providing practical and strategic legal advice on a broad range of issues.
• Provides product support counseling for one or more Regeneron products/product candidates from development through commercialization and lifecycle planning including:
Counseling on launch preparation activities for product candidates,
Advising on brand-related strategic planning and business operating plans
Reviewing and approving promotional materials and strategies
Advising on FDA regulatory submissions and label negotiations
Reviewing and approving medical materials and publications
Providing day-to-day counseling on advertising and promotion, drug safety, scientific exchange, strategic commercial activities, interactions with healthcare professionals, and external funding activities.
Training and educating clients on enforcement trends and discrete legal issues.
• Provides counsel and support to Compliance, including supporting policy development and providing training to commercial, medical, sales and other departments • Assists with a broad range of other healthcare regulatory matters including monitoring the enforcement environment, client training, compliance monitoring and investigations, market access, patient advocacy, contracts, patient assistance programs, and policy development.
• JD with 5+ years relevant legal experience • Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. • Prior in-house healthcare/pharmaceutical and/or biotech experience required. • Significant knowledge of life sciences regulatory enforcement trends, the FDCA, the false claims act, and fraud and abuse laws • Excellent interpersonal and conflict resolution skills and ability to work in highly collaborative, team-oriented environment. Essential Skills and Abilities • Exceptional oral and written communication skills, including drafting skills, and presentation capabilities. • Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations. • History of self-motivation, working independently on projects, meeting aggressive deadlines, and juggling multiple matters. • Market access counseling experience a plus.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
Additional Salary Information: bonus plus stock options
Internal Number: 13089BR
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.