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CMC Regulatory Affairs Expert

1 week ago

Gisborne, Gisborne, New Zealand Parexel International Full time

About the Role

The Senior Regulatory Affairs Consultant, FSP at Parexel International will provide strategic regulatory guidance to cross-functional teams responsible for product development and post marketing commitments. The ideal candidate will have significant experience with registration of Combination Products/Medical Devices, knowledge of regulatory framework for Combination Products/Medical Devices in major markets, and proven track record of contributing to design and execution of creative development strategies.

Key Responsibilities

  1. Develop and implement global CMC regulatory strategies
  2. Lead cross-functional project teams to execute agreed-upon strategies
  3. Negotiate agreements with regulatory agencies
  4. Coordinate planning and conduct of regulatory agency meetings on CMC

Requirements

  • Bachelor's or Master's degree in a scientific discipline
  • PhD or PharmD or equivalent experience strongly preferred
  • Regulatory Affairs Certification highly preferred
  • Minimum 6 years of CMC regulatory experience within pharmaceutical or biotechnology industry