Director and Corporate Counsel, Regulatory & Commercial Product Attorney

Regeneron Pharmaceuticals•Sleepy Hollow, NY

1d•Onsite

About The Position

The position with the Regeneron Regulatory and Commercial Law team will provide proactive and collaborative legal advice and counsel in connection with the commercialization of one or more of Regeneron’s products, and be part of a legal team supporting cardiovascular, hematology, rare disease, oncology, obesity, and new products. Counsel will be embedded as a core team member, serving as a strategic legal advisor to multiple internal stakeholders, including the commercial, medical affairs, regulatory, HEOR, corporate affairs, and compliance teams. Counsel will advise our internal partners through a deep understanding of (i) the complex laws and regulations and (ii) business and strategic objectives related to the discovery, development, and commercialization of biotechnology products. This role is based at Regeneron's offices in Sleepy Hollow, NY (4 days a week onsite) - it is not open to hybrid or fully remote assignments A typical day may include: : Providing day-to-day strategic and business-focused legal and risk counseling for one or more of Regeneron’s products/product candidates, from development through commercialization, including advising on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients. Demonstrating a solid understanding of the strategic and tactical objectives of the client teams supported, and advising on strategic brand and medical planning, developing creative and innovative solutions to key initiatives, considering the business objectives and priorities, as well as the US and/or international legal and regulatory landscape. Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease awareness, product communication, advertising and promotion, and strategic brand planning. Ensuring compliance with all relevant laws, regulations, policies, procedure and controls within relevant business areas supported Advising on data disclosures following clinical development milestones via press releases and US or international medical congresses and scientific exchange compliant with applicable laws and regulations. Liaising with other Law Department functions both in the US and globally, including litigation, IP, Compliance, and Transactions, to ensure integrated legal support and timely updates and information sharing. Reviewing relevant draft scientific publications and providing guidance as appropriate. Providing additional legal support on various matters for the Regulatory and Commercialization Law Team.

Requirements

Possess a solid understanding of the biotech/pharmaceutical industry, including product development, commercialization, and the legal and regulatory environment (including healthcare fraud and abuse, anti-kickback, and competition law) as practiced by a multinational pharmaceutical manufacturer
Deep knowledge of applicable statutory and regulatory frameworks governing the sale and marketing of biopharmaceuticals
Ability to handle multiple priorities in a dynamic and evolving environment
Excellent oral and written communication skills with a shown ability to present complex information accurately and concisely to influence others at all levels of management
Proven capacity to cultivate strong client relationships and influence leadership, including ability to assess and help business colleagues handle risks in a highly regulated environment
Have a JD with excellent law school credentials
Be licensed to practice law in New York or be eligible for licensure as a registered in-house counsel
Have at least 5 years of legal experience at a nationally recognized law practice in the area of pharmaceutical and healthcare law or as an in-house attorney at a biotech/pharmaceutical company.

Nice To Haves

Previous experience as a product attorney at a pharmaceutical or biotechnology company preferred

Responsibilities

Providing day-to-day strategic and business-focused legal and risk counseling for one or more of Regeneron’s products/product candidates, from development through commercialization, including advising on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, drug safety, market research, scientific exchange, and interactions with healthcare professionals and patients.
Demonstrating a solid understanding of the strategic and tactical objectives of the client teams supported, and advising on strategic brand and medical planning, developing creative and innovative solutions to key initiatives, considering the business objectives and priorities, as well as the US and/or international legal and regulatory landscape.
Counseling on all aspects of product commercialization, including launch preparation, launch execution, market development, disease awareness, product communication, advertising and promotion, and strategic brand planning.
Ensuring compliance with all relevant laws, regulations, policies, procedure and controls within relevant business areas supported
Advising on data disclosures following clinical development milestones via press releases and US or international medical congresses and scientific exchange compliant with applicable laws and regulations.
Liaising with other Law Department functions both in the US and globally, including litigation, IP, Compliance, and Transactions, to ensure integrated legal support and timely updates and information sharing.
Reviewing relevant draft scientific publications and providing guidance as appropriate.
Providing additional legal support on various matters for the Regulatory and Commercialization Law Team.

Benefits

comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

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