Alternance En Compliance Pharmaceutique / Réglementaire Site H/f

GSK

Evreux, France
Evaluate regulatory impacts according to guidelines
Maintain marketing authorization dossiers (amm)
Coordinate with central regulatory affairs teams
The role involves evaluating regulatory impacts and maintaining Marketing Authorization Dossiers within the Quality Regulatory team

Job Summary

  • The role involves evaluating regulatory impacts and maintaining Marketing Authorization Dossiers within the Quality Regulatory team.
  • Candidates must communicate changes to central Regulatory Affairs and coordinate the collection of necessary documents for regulatory files.
  • GSK Evreux is a major industrial site producing respiratory medicines, contributing over 10% to the company's global revenue.

Matching Summary

The role involves evaluating regulatory impacts and maintaining Marketing Authorization Dossiers within the Quality Regulatory team.

Skills & Requirements

Must-have

  • Evaluate regulatory impacts according to guidelines
  • Maintain Marketing Authorization Dossiers (AMM)
  • Coordinate with central Regulatory Affairs teams
  • Conduct regulatory monitoring and compliance checks
  • Analyze discrepancies between practices and regulations

Nice-to-have

  • Strong rigor and methodology skills
  • Curiosity for continuous improvement
  • Experience in respiratory medicine manufacturing
  • Ability to propose improvement actions

Key Requirements

  • Engineering or Pharmacy degree with specialized Master's in regulation
  • English reading and writing proficiency (TOEIC min 750)
  • Rigor, methodology, and curiosity as key soft skills

Work Rights

Not specified

Tailored Resume

Cover Letter