TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

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RA Manager

Department :  CD&RA
Working place :  Beijing
Recruitment :  1
Nature of work :  Full-Time
Working years of :  5+ years experience
Minimum academic :  Bachelor
Release time :  08 Jul, 2021
Job Responsibilities
  • 1. Support the execution of regulatory strategy for new products development.

  • 2. Support registration dossiers preparation, applications and approvals for new products within the set time frame.

  • 3. Support the IND maintenance and future license maintenance, e.g. DSUR, supplementary application, etc.

  • 4. Coordinate and follow up the project progress/timeline with internal and external stakeholders in timely manner.

  • 5. Support RA team to be updated on the upcoming significant changes of regulations or new regulations.

  • 6. Support RA team to develop or enhance regulatory related SOPs, systems, working procedures, etc. to ensure team operational efficiency, quality and compliance .

Job Requirements
  • 1. Scientific degree ( Pharmaceutical, biological or medical degree preferred)

  • 2. Proven ability to communicate (written/oral) in English

  • 3. 5+ years experience in Regulatory Affairs

  • 4.Good verbal and written communication skills with internal and external stakeholders