모집부문 : Regulatory Affair
 
주요업무


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


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



 
[자격요건]




bachelor's degree in Pharmacy – 약사 필수

Fluent in English


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