Associate Director, R&D Legal Operations

As part of the R&D Legal Operations Department, this Attorney will provide legal support to the Research and Global Development teams supporting Regeneron’s robust drug pipeline. The Associate Director will be responsible for providing advice and counsel on a wide range of legal and regulatory issues related to drug discovery and development. The attorney will serve as a proactive, solutions-oriented ethical counselor to internal Regeneron teams.  

As an R&D Attorney, a typical day may include:

• Provides advice and counsel to teams accountable for clinical studies across the Hematology therapeutic area
• Partner with Regulatory and Global Patient Safety teams to ensure compliance with laws and regulations
• Provide legal support to teams handling GCP non-compliance investigations
• Serve as a subject matter authority on R&D matters within the Law Department and collaborate with other legal functions (e.g., Business Development and Contracting, Compliance, Litigation and Products/Regulatory Law group)
• Conduct training to client groups on a variety of legal and regulatory issues

This role may be for you if you have:

• Experience with regulations and laws impacting the Research and Development departments within the biopharmaceutical industry.  These include ICH GCP, US FDA regulations relating to clinical trials, GDPR and other privacy laws
• Working knowledge and understanding of the Food, Drug & Cosmetic Act, Anti-Kickback statute, Foreign Corrupt Practices Act a plus
• Proficient in drafting and negotiation of Clinical Trial Agreements and Informed Consent Forms
• Understanding of biopharmaceutical industry trends, legislative initiatives and impact on Regeneron
• Strong interpersonal skills, including diplomacy and flexibility, and the ability to communicate effectively with personnel at all levels
• Good judgment and ability to maintain an objective perspective, particularly when determining the legal risk of clinical matters
• Ability to work well independently and on a team and can prioritize multiple matters
• Resilience and patience while supporting a complex growing clinical business

To be considered for this position you must posses BA/BS and JD with excellent law school credentials. Licensed to practice law in New York or be eligible for licensure as a registered in-house counsel with 5+ years experience. In-house biotech/pharmaceutical experience a significant plus.

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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.