Regulatory Consultant (row Mkt Exp And Cmc – Module 3 Exp)

SyneosHealth

Row markets experience
Cmc module 3 expertise
Post-approval variations management
The role requires a candidate with specific experience in ROW markets and CMC Module 3 for regulatory submissions

Job Summary

  • The role requires a candidate with specific experience in ROW markets and CMC Module 3 for regulatory submissions.
  • Candidates must have demonstrated experience managing post-approval variations and responding to Health Authority Questions.
  • Syneos Health is committed to building an inclusive culture where colleagues can authentically be themselves while driving patient progress.

Matching Summary

The role requires a candidate with specific experience in ROW markets and CMC Module 3 for regulatory submissions.

Skills & Requirements

Must-have

  • ROW markets experience
  • CMC Module 3 expertise
  • Post-approval variations management
  • API & Drug Product variations
  • Site transfer experience
  • Responding to Health Authority Questions

Nice-to-have

  • Ability to work independently
  • Cross-functional collaboration skills
  • Strong analytical skills
  • Excellent written communication
  • Proactive problem solving

Key Requirements

  • 6–9 years of relevant experience
  • BS or PhD degree in science-related field
  • Experience with IND, NDA, MAA, and CTD submissions

Work Rights

Not specified

Tailored Resume

Cover Letter