Regulatory Affairs Manager

GSK

Philippines
Hybrid
Bachelor's degree in pharmacy or life sciences
Minimum 3 years regulatory affairs experience
Practical knowledge of ctd structure
This role leads CMC regulatory activities to support product registrations and lifecycle maintenance in the Philippines

Job Summary

  • This role leads CMC regulatory activities to support product registrations and lifecycle maintenance in the Philippines.
  • The position requires collaborating with manufacturing, quality, supply, and local regulatory teams to meet strict submission timelines.
  • GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing.

Matching Summary

This role leads CMC regulatory activities to support product registrations and lifecycle maintenance in the Philippines.

Skills & Requirements

Must-have

  • Bachelor's degree in Pharmacy or Life Sciences
  • Minimum 3 years regulatory affairs experience
  • Practical knowledge of CTD structure
  • Experience preparing Module 3 content
  • Strong written and spoken English skills

Nice-to-have

  • Master's degree in relevant scientific discipline
  • Experience with eCTD publishing tools
  • Knowledge of multiple international markets
  • Cross-functional matrix team experience
  • Prior mentoring or training junior colleagues

Key Requirements

  • Bachelor's degree in Pharmacy, Chemistry, or related field
  • 3+ years experience in pharmaceutical regulatory affairs
  • Exposure to CMC activities and submissions

Work Rights

Not specified

Tailored Resume

Cover Letter