1. 모집부문 : Regulatory Affair
2.  
3. 주요업무

      1.Lead new product registration and life cycle management of existing licenses for medicinal products and medical devices  

2. Evaluate business impact due to local regulation changes and report this information to local and global management team
3. Proceed reimbursement price listing for new product and management reimbursement price adjustment by HIRA and MOHW
4. Review and approve local packaging materials for all products launched in South Korea 
5. Provide product information to the internal employees and external customers whenever requested according to the local and global SOPs
6. Review and approve promotional materials according to the local and global SOPs 
7. Lead to set up and maintain PV documentation system and monitor the systems to meet both local regulations and global SOPs
8. Prepare and attend internal GVP audit by CQM and follow up CAPAs
9. Local management of Investigator Initiated Studies 
10. Operate local clinical studies performed in South Korea

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  [자격요건]

1. bachelor's degree in Pharmacy – 약사 필수

   Fluent in English

2. Over 10 years’ experience in the pharmaceutical industry, including management of all different regulatory affairs processes.