A Generic Pharmaceutical company with a global outreach is looking for a driven Regulatory Affairs professional to join their fast-paced team. This person will work closely with other members of the team to and operate as the key U.S. contact with the FDA.
- Operate as the U.S. lead for generic drug products
- Oversee and develop junior members of the Regulatory team
- Perform CMC related activities, including writing and review
- 4-7 years experience in Regulatory Affairs
- 2 years of management in previous positions
- Extensive knowledge of Regulatory CMC submissions and processes, as well as ANDA, IND, NDA, and BLA
If you are interested in this role, please apply here.