외자계-RA팀장업무 (차-부장급)

나우팜컨설팅

  • 한국
  • 정규직
  • 풀타임
  • 2일 전
  • 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 필수Fluent in EnglishOver 10 years' experience in the pharmaceutical industry, including management of all different regulatory affairs processes.

나우팜컨설팅