Regulatory Site Officer

Sanrafaelvet

Regulatory dossier preparation
Compliance evaluation
Pharmaceutical product documentation
You will work in a regulatory excellence school, learning from experts and contributing to projects that impact millions of patients

Job Summary

  • You will work in a regulatory excellence school, learning from experts and contributing to projects that impact millions of patients.
  • The role involves drafting and reviewing regulatory variation dossiers, managing product renewals and registrations, and ensuring compliance with analytical and manufacturing documentation.
  • The Riells site is transitioning from Sanofi to Adamed, with initial employment under Sanofi and subsequent transfer to Adamed, reflecting a collaborative and secure data management environment.

Matching Summary

You will work in a regulatory excellence school, learning from experts and contributing to projects that impact millions of patients.

Skills & Requirements

Must-have

  • Regulatory dossier preparation
  • Compliance evaluation
  • Pharmaceutical product documentation
  • High-level English proficiency
  • Regulatory variation management
  • Knowledge of pharmaceutical regulations
  • Experience with Module 3 dossiers

Nice-to-have

  • French language skills
  • Teamwork and communication skills
  • Analytical and synthesis capability
  • Practical and methodical profile
  • Experience with pharmaceutical product transfers

Key Requirements

  • Degree in Pharmacy or Chemistry preferred
  • Experience with Module 3 regulatory dossiers for solid pharmaceutical forms
  • High-level English proficiency
  • Experience in regulatory variation writing and health authority responses
  • Knowledge of pharmaceutical manufacturing and CMC documentation
  • Experience in pharmaceutical product transfers

Work Rights

Not specified

Tailored Resume

Cover Letter