Regulatory Affairs Manager - Emerging Markets

jobs.abbott

Weesp, Netherlands
Base: n/a; bonus/equity: not specified; benefits: ...
Lead global regulatory strategies for emerging markets
Prepare complex registration packages and submissions
Evaluate scientific evidence against regulatory standards
This senior role provides high-level regulatory leadership for global development programs across Emerging Markets excluding Switzerland, the US, Europe, Canada, and Australia

Job Summary

  • This senior role provides high-level regulatory leadership for global development programs across Emerging Markets excluding Switzerland, the US, Europe, Canada, and Australia.
  • The position requires leading the preparation and approval of complex registration packages while ensuring robust dossier quality and alignment with cross-functional stakeholders.
  • Candidates will serve as the primary representative for in-licensing opportunities, independently evaluating regulatory risks and integration pathways.

Matching Summary

This senior role provides high-level regulatory leadership for global development programs across Emerging Markets excluding Switzerland, the US, Europe, Canada, and Australia.

Salary

Base: N/A; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Lead global regulatory strategies for emerging markets
  • Prepare complex registration packages and submissions
  • Evaluate scientific evidence against regulatory standards
  • Manage product life cycle compliance activities
  • Represent company in Health Authority interactions

Nice-to-have

  • Experience with in-licensing due diligence evaluations
  • Strong cross-functional leadership capabilities
  • Ability to streamline regulatory processes
  • Expert knowledge of evolving global guidelines

Key Requirements

  • Bachelor's degree in Pharmacy, Biology, Chemistry, or related field
  • Advanced degree (Master's) strongly preferred
  • Experience managing regulatory submissions for commercial products

Work Rights

Not specified

Tailored Resume

Cover Letter