Assistant General Counsel - FDA Regulatory & Commercial jobs in United States
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Regeneron · 20 hours ago

Assistant General Counsel - FDA Regulatory & Commercial

Regeneron is a biotechnology company that is seeking an Assistant General Counsel to provide legal advice and counsel regarding the commercialization of its products. The role involves advising on healthcare regulatory matters, product commercialization, and ensuring compliance with relevant laws and regulations.

BiopharmaBiotechnologyPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Providing day-to-day strategic and business-focused legal and risk counseling for Regeneron’s products/product candidates, from development through commercialization
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

Qualification

Pharmaceutical lawHealthcare regulatory mattersProduct commercializationLegal experienceClient relationship managementAnalytical skillsLearning agilityOral communicationWritten communication

Required

JD with excellent law school credentials
Licensed to practice law in New York or eligible for licensure as a registered in-house counsel
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
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

Preferred

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

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

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Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.

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 Company
Total Funding
$15.93M
Key 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

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Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
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Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
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Company data provided by crunchbase