Regulatory Affairs Manager

WHITE GATE PARTNERS PTE. LTD.

Singapore
Not specified
5 years regulatory affairs experience
Sea market submission management
Asean ctd and ectd knowledge
WHITE GATE PARTNERS PTE. LTD. is seeking a Regulatory Affairs Manager to support pharmaceutical product compliance and market access in Southeast Asia. The ideal candidate will have at least five years of regulatory experience and a strong understanding of local regulations across multiple Southeast Asian markets

Job Summary

  • The role involves developing and implementing regulatory strategies for product launches across Southeast Asia.
  • Candidates will prepare and submit dossiers for new registrations, renewals, and variations following local requirements.
  • The position requires overseeing the full registration process to ensure timely approvals and compliance with regional regulations.

Matching Summary

Match Score: 85

WHITE GATE PARTNERS PTE. LTD. is seeking a Regulatory Affairs Manager to support pharmaceutical product compliance and market access in Southeast Asia. The ideal candidate will have at least five years of regulatory experience and a strong understanding of local regulations across multiple Southeast Asian markets.

Skills & Requirements

Must-have

  • 5 years regulatory affairs experience
  • SEA market submission management
  • ASEAN CTD and eCTD knowledge

Nice-to-have

  • Strong stakeholder management skills
  • Ability to work independently
  • Fast-paced environment adaptability

Key Requirements

  • Bachelor's degree in pharmacy or Life Sciences
  • Minimum 5 years of pharmaceutical regulatory experience
  • Proven experience managing submissions across multiple SEA markets

Work Rights

Not specified

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