人才招募
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招聘信息 | 2020-03-11

註冊總監

Primary function: Product registration

 

Responsibilities

  • 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 for regulatory needs of HMPL with external stakeholders
  • Implement regulatory activities as required by governmental regulations and internal SOPs
  • Provide input to regulatory strategy & timeline and form accelerate Strategy for product registration
  • Provide regulatory intelligence and policy interpretation

 

Secondary function: People management

Responsibilities

  • Lead a small RA team in Beijing as line manager
  • Supervise team members and provide training and support to their daily work

 

Qualifications

  • Bachelor degree and above in Pharmacy or Pharmaceutical
  • 10 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
  • Good understanding of regulatory policy, GCP and ICH guidelines