Regulatory Affairs Manager

GSK

Philippines
Hybrid
Cmc regulatory dossier preparation
Regulatory submissions and variations
Cross-functional collaboration
You will lead CMC regulatory activities to support product registrations and lifecycle maintenance in the Philippines

Job Summary

  • You will lead CMC regulatory activities to support product registrations and lifecycle maintenance in the Philippines.
  • This role offers strong growth, meaningful impact on patient access, and the chance to develop global regulatory expertise while helping GSK unite science, technology and talent to get ahead of disease together.
  • GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

Matching Summary

You will lead CMC regulatory activities to support product registrations and lifecycle maintenance in the Philippines.

Skills & Requirements

Must-have

  • CMC regulatory dossier preparation
  • Regulatory submissions and variations
  • Cross-functional collaboration
  • Regulatory compliance and risk management
  • Document writing and review
  • Managing submission timelines

Nice-to-have

  • Mentoring junior colleagues
  • Experience with eCTD publishing tools
  • Knowledge of international regulatory requirements
  • Working in global matrix teams
  • Process improvement contributions
  • Curious and collaborative mindset
  • Commitment to patient safety

Key Requirements

  • Bachelor’s degree in Pharmacy or related field
  • Minimum 3 years regulatory affairs experience
  • Practical knowledge of CTD structure
  • Experience preparing Module 3 content
  • Strong written and spoken English
  • Ability to manage multiple tasks to deadlines

Work Rights

Not specified

Tailored Resume

Cover Letter