Regulatory Specialist

Bristol Myers Squibb

Shanghai, China
50% onsite
Manage regulatory affairs gmp
Communicate with shfda
Host government inspections
Cooperate with ShFDA and manage regulatory affairs related to GMP in SASS, making sure SASS operation meets regulatory requirements

Job Summary

  • Cooperate with ShFDA and manage regulatory affairs related to GMP in SASS, making sure SASS operation meets regulatory requirements.
  • Communicate with ShFDA in time to ensure that the relevant register work meets the requirements of government regulations.
  • Host government official for regulatory inspecting and GMP audit, and get a satisfactory inspection result with less findings.

Matching Summary

Cooperate with ShFDA and manage regulatory affairs related to GMP in SASS, making sure SASS operation meets regulatory requirements.

Skills & Requirements

Must-have

  • Manage regulatory affairs GMP
  • Communicate with ShFDA
  • Host government inspections
  • Perform GMP internal audit
  • Push CAPA for findings

Nice-to-have

  • Business excellence and Lean idea
  • Influence and encourage staff
  • Accountability and decision making

Key Requirements

  • Years of experience not specified
  • Education not specified
  • Work authorization not specified

Work Rights

Not specified

Tailored Resume

Cover Letter