Job Position: 바이오시밀러/전문의약품 등록업무(RA)
Job Description: Seoul – 바이오시밀러/전문의약품 등록업무(RA) 2017.08.23 JOB Profile for Regulatory Affairs Manager Designation: Regulatory Affairs Manager Reporting to: Direct report: Regional Business Head – North Asia Functional Reporting: Regional Regulatory Manager – APAC Experience: – At least 8 to 10 years professional experience in managing ethical pharmaceutical products (generics) regulatory / registration activities with MFDS-Korea. – Must be License Pharmacist Location: Seoul, South Korea Function: Regulatory Affairs Products: Portfolio of Pharmaceutical generic molecules (Oncology & Non-Oncology) Job Profile: Regulatory Affairs: Compilation and preparation of dossiers as per local South Korea Pharmaceutical regulatory – MFDS requirement. Submission and co-ordination with MFDS-South Korea and with regulatory / technical team at head quarter. Incase of requirement of doing local pharmaco-equivalence for injectable products, finding out and co-ordinating with local laboratory for perfor…see more details
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