GRA CMC Manager
CSL Innovation(1 month ago)
About this role
The GRA CMC Manager leads global CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management. The role shapes overall CMC regulatory strategy, ensures compliant execution of submissions and changes, and partners with technical and regulatory teams worldwide to support approvals for biological products.
Required Skills
- CMC Strategy
- Regulatory Submissions
- Dossier Authoring
- GMP Inspections
- Technical Liaison
- Impact Assessment
- Risk Assessment
- Project Management
- Stakeholder Management
- Regulatory Intelligence
+5 more
Qualifications
- BS in Natural Sciences
- MS in Natural Sciences
- Degree in Regulatory Affairs (advantageous)
About CSL Innovation
csl.comCSL is a leading global biotechnology company dedicated to creating lifesaving medicines. With a portfolio that includes therapies for rare diseases, immune deficiencies, and vaccines for influenza, CSL's mission is rooted in innovation and public health. The organization comprises three distinct businesses: CSL Behring, focused on plasma-derived therapies; CSL Seqirus, specializing in influenza vaccines; and CSL Vifor, addressing iron deficiency and nephrology. Since its founding in 1916, CSL has been committed to ensuring access to essential treatments for patients in over 100 countries.
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