Associate Director, Corporate Counsel - Regulatory and Commercial
September 6, 2018
Tarrytown, New York
Full Time - Experienced
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 proactive and collaborative legal support in connection with one or more of Regeneron’s products as well as legal advice to a wide range of internal clients, including sales, marketing, 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 the discovery, development, 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.
• Oversee the review and approval of external funding requests, including educational grants, sponsorships, collaborations, and charitable donations. Will serve as voting legal member on relevant external funding committees and proactively help to develop and improve necessary policies and procedures. • Review and approve needs assessments in connection with proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements. • Provide product support counseling for one or more Regeneron products/product candidates from development through commercialization and lifecycle planning. • Provide legal support as needed on patient assistance programs and market access contracts. • Assist with a broad range of other healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development.
*Experience and Required Skills:
• JD with 5+ years relevant legal experience • Licensed to practice law in New York or eligible for licensure as a registered in-house counsel. • Prior in-house healthcare/pharmaceutical and/or biotech experience strongly preferred. • Significant knowledge of life sciences regulatory enforcement trends, the FDCA, the false claims act, and fraud and abuse laws Essential Skills and Abilities • Exceptional oral and written communication skills, including drafting skills, and presentation capabilities. • Excellent interpersonal and conflict resolution skills and ability to work in highly collaborative, team-oriented environment. • 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.
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: base, bonus, and stock options
Internal Number: 14101BR
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.