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 development pipeline. This role will be responsible for providing advice and counsel on a wide range of legal and regulatory issues related to drug discovery and development and will serve as a proactive, ethical counselor to Regeneron's teams.
As the Director, R&D Attorney a typical day may include:
- Providing advice and counsel to teams accountable for clinical studies in the Immunology and Inflammation therapeutic area
- Partnering with Clinical Development, Regulatory and Global Patient Safety teams to ensure compliance with laws and regulations
- Providing legal support to teams handling GCP non-compliance investigations
- Serving 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, Data Protection/Privacy, Litigation and Products/Regulatory Law group)
- Conducting training to client groups on a variety of 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 and other privacy laws
- Working knowledge and 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 solid understanding of the biotech/pharmaceutical or medical device 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 to 10 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)