Global Regulatory Affairs Specialist

Responsibilities

• Review global regulatory requirements and perform gap analysis for blood products
• Manage international product licenses and oversee life cycle 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 provide regulatory expertise
• Prepare for and support on-site GMP inspections

Requirements

• Bachelor's degree or higher in Pharmacy, Biology, Biotechnology, Chemistry, or other Natural Sciences
• Minimum of 3 years of professional experience in regulatory affairs

Preferred Qualifications

• Proven experience in preparing CTD documentation for international regulatory submissions
• High proficiency in English, including professional business writing and verbal communication skills

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.