Assistant General Counsel - FDA Regulatory & Commercial

Role Summary

This 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. 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.

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.

Qualifications

• Required: JD with excellent law school credentials; licensed to practice law in New York or eligible for in-house counsel licensure; 10+ years of legal experience, including in-house experience at a biotech/pharmaceutical company and at a nationally recognized firm in pharmaceutical and healthcare law; solid understanding of the biotech/pharmaceutical industry, including product development, commercialization, and the legal/regulatory environment (healthcare fraud and abuse, anti-kickback, and competition law); deep knowledge of statutory and regulatory frameworks governing the sale and marketing of biopharmaceuticals.
• Preferred: Previous experience as a product attorney at a pharmaceutical or biotechnology company; 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; proven ability to cultivate strong client relationships and influence leadership; strong analytical skills and learning agility; strong teamwork and collaboration across multiple functional areas.

Skills

• Excellent oral and written communication
• Strong analytical skills and learning agility; deep aptitude for science and data analysis
• Ability to build and maintain relationships; influence leadership and cross-functional teams
• Strategic thinking with a practical, risk-based approach to regulatory and commercial challenges