Director – Product Counsel – Fda
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Tarrytown, NY, USA |
| Salary | $202000 – $336600 |
| Type | Full-Time |
| Degrees | JD |
| Experience Level | Senior, Expert or higher |
Requirements
- 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
- At least 3 years of legal experience at a nationally recognized law practice, preferably in-house biotech/pharmaceutical and/or healthcare experience
- Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel
- JD with excellent law school credentials
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 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.
Preferred Qualifications
- Previous experience as a product attorney at a pharmaceutical or biotechnology company preferred.