We are looking for a Director of Regulatory Affairs CMC to join a dynamic and fast paced Biotechnology Research organization.
The Director of Regulatory CMC will be responsible for:
- Oversee Global Health Authority interaction related to Regulatory CMC matters/inquiries
- Represent the Regulatory CMC function in cross-functional meetings and collaborative work
- Manage Regulatory CMC strategies for full life cycle development of drug products
- Review technical aspects of global submissions including but not limited to- IND, BLA, MAA
The Director of Regulatory CMC should have the following qualifications:
- At least 12 years of Global Regulatory CMC experience
- Strong background within the Biologics space related to CMC
- Experience working with supporting teams cross-functionally
If you are interested in this opportunity, please apply here.