Director, Product Counsel (FDA) - Regeneron Pharmaceuticals : Job Details

We are looking for a Director Product Counsel for the Regeneron Regulatory and Commercial Law team to provide proactive and collaborative legal advice and counsel in connection with the commercialization of one or more of Regenerons products, including support for our leading product in the allergic and inflammatory disease therapeutic area. Counsel will be embedded as a core team member, serving as a strategic legal advisor to multiple internal partners, 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 with anticipated newly approved indications, and providing practical and strategic legal advice on a broad range of issues.

A typical day might include:

• Providing day-to-day strategic and business-focused legal and risk counseling for one or more of Regenerons products/product candidates, from development through commercialization, including advising on a broad range of healthcare regulatory matters, including labeling negotiations, advertising and promotion, drug safety, market research, scientific exchange, market access and patient support initiatives, 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 achievements via press releases and US or international medical congresses and scientific exchange aligned 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.

This role might be for you if you have:

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

We are looking for at least 5 years of legal experience at a nationally recognized law practice, with at least 2 years of in-house biotech/pharmaceutical and/or healthcare experience and be licensed to practice law in New York or be eligible for licensure as a registered in-house counsel. We also require a JD with excellent law school credentials. Some travel is required (US and limited international). This role requires working onsite a minimum of 3 days per week.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)