Regeneron · 6 days ago
Assistant General Counsel - FDA Regulatory & Commercial
Sleepy Hollow, NY
Full-time
Onsite
Senior Level, Lead/Staff
$238K/yr - $397K/yr
10+ years expRegeneron is a leading biotechnology company focused on the commercialization of innovative products. They are seeking an Assistant General Counsel to provide legal advice and counsel related to the commercialization of their products, supporting various internal stakeholders and ensuring compliance with healthcare regulations.
BiopharmaBiotechnologyPharmaceutical
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
Qualification
Required
Possess 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 10+ years of legal experience, including positions as an in-house attorney at a biotech/pharmaceutical company, and at a nationally recognized law practice in the area of pharmaceutical and healthcare law
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
Preferred
Previous experience as a product attorney at a pharmaceutical or biotechnology company preferred
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
Strong analytical skills and demonstrated learning agility and a deep aptitude for science and data analysis
Committed to teamwork and collaboration across multiple functional areas
Benefits
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
Paid leaves (e.g., military and parental leave)
Company
Regeneron
Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.
10001+ employees
H1B Sponsorship
Regeneron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)
Funding
Current Stage
Public CompanyTotal Funding
$15.93MKey Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M
Leadership Team
Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase