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临床及注册, 北京 | 2021-09-30

Associate Director (AD), Regulatory Affairs

Job Title: Associate Director (AD), Regulatory Affairs
Location: Beijing

Major Responsibilities and Duties

  • Review product registration dossier and relevant documents
  • Obtain IND & NDA approval as well as product registration license renewal as planed
  • Coordinate with each function within HMPL from registration pathway
  • Establish and maintain relationship with external stakeholders
  • Liaise with external stakeholders for regulatory needs of HMPL
  • Implement regulatory activities as required by governmental regulations and internal SOPs
  • Form accelerate Strategy for product registration

Qualifications:

  • Bachelor degree and above in Pharmacy or Pharmaceutical
  • 7 years or more drug registration experience in pharmaceutical industry
  • Prefer oncology drug registration background
  • Good understanding of Chinese pharmaceutical & regulatory environment
  • Good relation with stakeholders related to product registration
  • Fluent English
  • Strong communication skill
  • Passion in drug development

Internal-External Relations

  • Internal: RA team, CR team, Research dept., CMC Dept., GA Dept., etc.
  • External: NMPA, CDE, NIFDC, CFDI, CHP, etc.

If interested, please forward your resume to KellyL@hutch-med.com