Job Summary
A staffing agency is seeking a Telecommute Biosimilar Regulatory Strategist.
Individual must be able to fulfill the following responsibilities:
- Ensuring that regulatory documents are prepared accurately, completely and on-time
- Developing regulatory post-approval filing strategies and variations for global products
- Liaising with Global Regulatory Team to progress the submission/project support
Qualifications for this position include:
- Minimum Bachelor’s degree in a scientific discipline
- Minimum of 5 years of regulatory experience
- Broad functional knowledge of pharmaceutical sciences
- Clear understanding of drug development or manufacturing/improvement processes
- Thorough understanding of CMC regulatory change management requirements
- Strong knowledge in global post-approval CMC change regulations