A global Biotechnology Research company is hiring for a Regulatory CMC Specialist/Manager to join their team. They are looking for motivated individuals who are accustom to working in a fast-paced work environment.
- Prepare and review documents, ensuring compliance with Regulatory Health Authorities
- Lead the submission process of IND, NDA, MAA, BLA
- Represent the Regulatory team in meetings with third party vendors and/or relevant cross functional teams
- Serve as the go to Regulatory CMC team member
- Bachelor's Degree or higher required in applicable science field or equivalent
- At least 3 years of experience in the Biopharmaceutical industry
- 3 years working hands on in Regulatory CMC (Biologics preferred)
If you are interested in this position, please apply here.