Associate Director, Corporate Counsel - Regulatory & Commercial

This position with the Regulatory and Commercial Law team will provide proactive and collaborative legal support in connection one or more of Regeneron’s products and will act as an advisor to our sales, marketing, medical affairs, regulatory, and compliance teams. The role will counsel our ipartners through a deep understanding of healthcare laws, including the Food, Drug and Cosmetic Act, and laws related to the discovery, development, sales and marketing of biotechnology products (including healthcare fraud and abuse laws). 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.

As a Regulatory and Commercial Law Corporate Counsel, a typical day may include:

• Providing day-to-day strategic legal counseling, as lead risk counselor, for one or more of Regeneron’s products/product candidates from development through commercialization and lifecycle planning, including advising on a broad range of healthcare regulatory matters, including advertising and promotion, privacy, drug safety, market research, scientific exchange, interactions with healthcare professionals, market access, patient support programs, and external funding requests.
• Provide business-focused legal guidance and counsel to commercial, medical, clinical, regulatory, compliance, market access and policy with a focus on healthcare laws, regulations, and the overall healthcare environment
• Demonstrating an understanding of the strategic and tactical objectives of the client teams supported, developing creative and innovative solutions to key initiatives, taking into account the current legal and regulatory landscape
• Utilizing a deep knowledge of pipeline and approved products to advise on BLA-submission activities, labeling, safety and risk mitigation development and activities
• Counseling on all aspects of product commercialization, including launch preparation, launch execution, advertising and promotion, product communications, and strategic brand planning. Work collaboratively to support Compliance in their mission of developing policies, training, procedures, monitoring, risk mitigation and their support of the seven elements of an effective compliance program
• Acting as a cross-functional liaison with the Intellectual Property, Dispute Resolution, Transactions and other key Law Department groups.
• Reviewing and approving of needs assessments of proposed engagements with healthcare professionals, including those in connection with speaker and general consulting engagements.
• Assisting with a broad range of healthcare regulatory matters including monitoring the enforcement environment, client training, and compliance policy development.

This role might be for you if you:

• Have outstanding interpersonal and conflict resolution skills
• Work well independently, while meeting aggressive deadlines and prioritizing multiple matters
• Collaborate closely with internal clients (including scientific and business leaders) with strategic transactions
• Have exceptional oral and written communication skills
• Maintain an independent and objective perspective while developing and maintaining a strong partnership with client organizations and protecting Regeneron’s interests
• Work effectively and expertly with colleagues & clients in a collaborative environment
• Collaborate and advise key stakeholders, including senior management, on contracts group policies and procedures

To be considered for this position, you must:

Possess a solid understanding of the biotech/pharmaceutical industry, including product development, commercialization, and the legal and regulatory environment. Have 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 at least 5+ years of legal experience at a law firm and/or in-house, including biotech/pharmaceutical and/or health care experience.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$162,600.00 - $265,400.00