Regulatory CMC Expert (manager), Japan
CSL Innovation(1 month ago)
About this role
The Regulatory CMC Expert in Japan evaluates CMC regulatory aspects for assigned development and established products and develops regional CMC strategies in line with global direction. The role prepares Japanese CMC regulatory dossiers and engages with Japanese health authorities while acting as a regional subject matter expert and liaison to global teams.
Required Skills
- CMC
- Regulatory Strategy
- Dossier Preparation
- CTD
- Gap Analysis
- Health Authorities
- Japanese Regulations
- Project Management
- Negotiation
- Leadership
+2 more
Qualifications
- Bachelor’s Degree in Life Science
- MSc
- PhD
- MD
- MBA
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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