Job Summary
A pharmaceutical and biotechnology development company is in need of a Remote Biologics Computer Mediated Communication Regulatory Affairs Executive Director.
Must be able to:
- Develop meaningful and collaborative relationships with local & global internal/ external partners
- Demonstrate success in influencing without positional authority within a highly matrixed organization
- Lead the integration and implementation of CMC Team Leaders and CMC Strategies
Must meet the following requirements for consideration:
- BA/BS with 16 years experience in biologics development, global CMC regulatory affairs, and CMC technical areas or
- MA/MS, PhD, PharmD, or MD with 14 years experience in biologics development, global CMC regulatory affairs, and CMC technical areas
- Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions
- Organizational leadership skills at both functional and enterprise levels
- Excellent strategic acumen, collaboration, and communication skills
