Director Legal Counsel - R&D / FDA Regulatory Attorney

Regeneron’s R&D Legal Operations Team is seeking an experienced attorney to partner with, and provide strategic legal advice to, the Global Research and Development teams that support Regeneron’s robust and growing pipeline. The attorney should have experience in regulatory law and R&D and will provide advice on a wide range of legal, regulatory, contractual, privacy, and compliance issues related to drug discovery and development. The attorney will be an integral part of a proactive and solutions-oriented legal team that provides advice to advance Regeneron’s pipeline.

As a Legal Counsel - R&D Regulatory Attorney, a typical day may include:

• Providing advice and counsel to global development programs in a designated therapeutic area
• Advising leaders in the Global Research and Development team and others on regulations and laws impacting the R&D teams
• Collaboratively interacting with internal business stakeholders, third party partners including CROs, and R&D management
• Drafting and negotiating a wide range of R&D agreements including clinical trial agreements and other contracts in support of our global clinical trial operations
• Counseling on patient privacy and patient rights on matters related to clinical research Serving as a subject matter expert on R&D matters within the Law Department and collaborate with other legal functions (e.g., Business Development and Contracting, Compliance, Data Protection/Privacy, Litigation and Products/Regulatory Law group)
• Conducting training to client groups on a variety of R&D legal and regulatory issues

This role may be for you if you possess:

• Experience with regulations and laws impacting the Research and Global Development departments within the biopharmaceutical industry. These include ICH GCP, US FDA regulations relating to clinical trials (21 CFR), EU Clinical Trial Regulations, EU GDPR, EU IVDR and MDR Deep understanding of the Food, Drug & Cosmetic Act, Anti-Kickback statute, Foreign Corrupt Practices Act a plus
• Proficiency in drafting and negotiating Clinical Trial Agreements and Informed Consent Forms
• An 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 partners at all levels
• Good judgment and ability to maintain an objective perspective, particularly when resolving legal risk of clinical matters
• Ability to work well independently and on a team and can prioritize multiple matters
• Resilience and perseverance while supporting a sophisticated growing clinical business

To be considered for this position, you must possess a JD with excellent law school credentials and 5 - 10 years of legal experience at a law firm and /or in-house within a Life Sciences company. A solid understanding of the biotech/pharmaceutical or medical device industry, and the legal and regulatory environment are also required. Be licensed to practice law in New York or be eligible for licensure as a registered in-house counsel.