Senior RA manager/Associate RA Director

Basic qualifications:

  • Establish, maintain and develop good relationships with the State Drug Administration (SDA), to facilitate and expedite regulatory approvals and as required with other regulatory authorities (CDE, NICPBP).
  • Advise and resolve specific issues to achieve agreed milestones and ensure that submitted documentation meets SDA and GSK requirements.
  • Ensure that GSK Bio. Regulatory Affairs are kept fully informed on the current regulatory status of all assigned products.
  • Ensure that Import product labeling and PI is consistent with SDA guidelines and requirements.
  • Order, translate, compile and prepare registration dossiers into an effective, professional document for submission to SFDA.
  • Draft for approval by the Manager, local prescribing information (PI) that it is both competitive and fully conforms with SFDA and GSK requirements.
  • Collect and communicate to the Manager any information that relates to the registration and administration of medicines in China; including new legislation, changes to the regulatory requirements, guidelines etc.
  • As required co-ordinate activities with GSK Bio RA.
  • Assist the Manager in supporting and providing a service to other functions and departments (e.g. Clinical and Marketing).

5.When the job holder becomes the member of QMS Implementation Team, she/he is responsible for her/his assigned supporting work.

Preferred qualifications:

1.Preparing and submitting the documentation for new registrations and renewal of existing regulatory approvals for finished product imports. Current scope includes:

  • Import :
  • Current products IDL renewal and its variation
  • New products registration
  • Localization: Repackaging license and its renewal

2.Commercial supplying: to trace all commercial goods CoAs from NICPBP

3.Cooperate with GSKBS GMP certificate

4.Regulatory Affairs:

  • Regulation search and distribute to relevant parties internally
  • Involve in regulation influence activities
  • Involve in related industry regulatory activities

Details:

Job Description Summary-Default Job Description

Job Description-

Contact information:

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