Regulatory Affairs Associate Manager

작업 내용

Regulatory Affairs Associate Manager

• Responsible for Drug license validity extension and all changes (ex, CMC-related changes)
• Cooperate with new product development clinical trials team in submission tasks (IND and amendments submissions)
• PMF registration and Follow up PMF registration/DMF registration
• New drug inspection registration/new indication registration
  
  

Criteria

• Professional Education background of Pharmacy
• With over 3 years of practical experience in license registration, PMF registration / IND submission experience is preferred
• English: Professional Working Proficiency