Our client, a publicly traded pharmaceutical company in New York is seeking an experienced regulatory attorney who will serve as a generalist and provide legal support to the Research and Global Development teams supporting the company’s robust drug discovery pipeline. In this role, you will have General Counsel functionality and will be the lead lawyer for a key therapeutic area. Responsibilities include counseling on pre-commercialization regulatory issues (not advertising or promotional review), contracts, privacy and compliance.
To be considered for this position, you must possess:
- 5 years of proven experience and a BA/BS and JD with excellent law school credentials.
- A license to practice law in New York or be eligible for licensure as a registered in-house counsel.
- Experience with regulations and laws impacting the Research and Development departments within the biopharmaceutical industry. These include ICH GCP, US FDA regulations (21 CFR) 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.
- Proficiency in drafting and optimizing Clinical Trial Agreements and Informed Consent Forms.
Salary commensurate with experience. Bonus and equity eligible position.Submit Resume