S
Posted 17 hours ago
Global Regulatory Affairs Specialist
SK plasmaGlobal RA
Requirements
Bachelor's degree or higher, Natural science major (Pharmacy, Biology, Biotechnology, Chemistry, etc.), 5+ years of RA experience, Proficient in English (writing and business conversation)
Skills
GMP
About the role
Responsibilities
- Review global regulatory requirements and perform gap analysis for blood products
- Manage international product licensing and lifecycle management
- Prepare global regulatory documentation, including CTD and Plasma Master Files
- Draft responses to inquiries and deficiency letters from regulatory agencies
- Support global business projects and regulatory strategy
- Prepare for and support on-site GMP inspections
Requirements
- Bachelor's degree or higher in a natural science field (Pharmacy, Biology, Biotechnology, Chemistry, etc.)
- 5+ years of experience in Regulatory Affairs (RA)
- Proficiency in English, including professional writing and business conversation skills
Preferred Qualifications
- Direct experience in preparing CTD documentation for international regulatory submissions
About the Company
SK plasma is a leading biotechnology company dedicated to providing essential blood products and life-saving therapies. We focus on innovation and excellence in the bio-sector to create a healthier world.
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SK plasma · Pangyo
