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Assistant General Counsel - FDA Regulatory & Commercial
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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.
This role is based at Regeneron's offices in Sleepy Hollow, NY (4 days a week onsite) - it is not open to hybrid or fully remote assignments
As an Assistant General Counsel a typical day may include:
- 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.
This role may be for you if you have:
- 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
To be considered for this role you must 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
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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.
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