Key skills
Communication
About this role
Role Overview
- Provide strategic and operational regulatory CMC expertise across global development projects
- Develop and execute global regulatory CMC strategies for biological products
- Collaborate with cross-functional colleagues to optimize product development
- Plan and prepare CMC documentation for clinical applications
Requirements
- Master of Science in pharmacy, engineering or equivalent
- Minimum 5-10 years of industry experience within Regulatory Affairs CMC
- Strong understanding of compliance and biologics
- Proficient communication in English (verbal and written)
Benefits
- Hybrid work model
- Collaborative team environment
- Opportunity to work on innovative projects