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Posted a day ago
Global Regulatory Affairs (Global RA)
SK plasmaGlobal RA
Requirements
Bachelor's degree or higher, Experience in RA, Pharmacy, Biology, Biotechnology, Chemistry, or Natural Science major, Proficiency in English documentation and business conversation
Skills
GMP
About the role
Responsibilities
- Review international blood product licensing regulations and perform regulatory gap analysis
- Manage international product licenses and oversee life cycle management
- Prepare international regulatory documentation, including CTD and Plasma Master Files
- Draft responses to inquiries and supplementary requests from regulatory agencies
- Prepare for and support on-site GMP inspections
Requirements
- Bachelor's degree or higher in Pharmacy, Biology, Biotechnology, Chemistry, or a related Natural Science field
- Proven professional experience in Regulatory Affairs (RA)
- Proficiency in English for technical documentation and business communication
Preferred Qualifications
- Experience in preparing CTD (Common Technical Document) for international licensing purposes
About the Company
SK plasma is a leader in the biotechnology sector, specializing in the development and production of essential blood products to improve global health.
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SK plasma · Pangyo
