ManagerSr. Manager - Regulatory Affairs
Gan & Lee PharmaceuticalsNew Jersey, United States
Posted January 5, 2026
Full Time
About the Company
Gan & Lee Pharmaceuticals, established in 1998, is a leading supplier of insulin and biosimilars in China, with global expansion plans. Headquartered in Beijing and operating in Linyi City, the company focuses on diabetes diagnosis and treatment, cardiovascular disease, metabolic disorders, cancer, and other therapeutic areas. Gan & Lee's commitment to patient care is reflected in its state-of-the-art facilities and clinical development program.
Job Description
This position will support the development and implementation of regulatory strategies, work with cross-functional teams to prepare and submit regulatory documents, and manage interactions with regulatory agencies.
Requirements
- Bachelor of Science Degree in a relevant area
- RAC certification or other equivalent
- Minimum 5+ years of pharmaceutical industrial experience
- At least 2 years of regulatory submission experience for product(s) development in the US and/or EU
- Experience supporting clinical development teams in the metabolic disease space
