Manager Regulatory CMC
argenx(4 months ago)
About this role
The Manager Regulatory CMC at argenx is responsible for providing Regulatory CMC expertise to support the global regulatory strategy and operations for large molecule therapeutic drug candidates. This role involves developing regulatory strategies, authoring submission packages, and coordinating with health authorities throughout the drug development process, while maintaining effective communication with external partners.
Required Skills
- Regulatory Strategy
- Project Management
- Quality Submissions
- Health Authorities Coordination
- Risk Assessment
Qualifications
- Master’s degree or PhD in Biotechnology
- Pharmaceutical Sciences or Bioengineering
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