Senior Regulatory Affairs Lead

2 months ago


Shanghai, Shanghai, China Abbott Full time

Job Description:

Regulatory Affairs Manager for Pharmaceutical Industry

Welcome to the Abbott team as a Regulatory Affairs Manager for Pharmaceutical Industry We are looking for a highly skilled and experienced professional to join our team.

About the Role:

  • Develop and implement regulatory strategies to ensure timely product approvals and compliance with CFDA regulations and guidelines.
  • Prepare and validate registration dossiers for CTA, NDA, Renewal, and variations, ensuring that all necessary documentation is complete and accurate.
  • Establish and maintain effective working relationships with regulatory authorities, including CFDA, CDE, and Institute for Drug Control.
  • Provide regulatory support to Medical and Marketing teams, as well as other company personnel, to ensure compliance with regulatory requirements.
  • Develop and implement internal processes and systems to support regulatory submissions and approvals in the most efficient manner.
  • Train and develop subordinates, provide good support, and well coordinate with colleagues to promote the best performance of team work.


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