Spécialiste Senior Audit Et Affaires Réglementaires H/f

GSK

Saint-Amand-les-Eaux, France
Conduct internal audits
Prepare regulatory documentation
Evaluate regulatory impact
As Senior Audit and Regulatory Affairs Specialist, you will lead audits and regulatory activities to ensure site compliance, working with quality, operations, and global regulatory affairs teams

Job Summary

  • As Senior Audit and Regulatory Affairs Specialist, you will lead audits and regulatory activities to ensure site compliance, working with quality, operations, and global regulatory affairs teams.
  • The role involves planning and conducting internal audits, preparing regulatory documentation, evaluating the regulatory impact of changes, and coordinating the implementation of corrective actions.
  • GSK is a leading biopharmaceutical company focused on preventing and treating diseases through vaccines and specialty medicines, with a mission to unite science, technology, and talent to get ahead of disease together.

Matching Summary

As Senior Audit and Regulatory Affairs Specialist, you will lead audits and regulatory activities to ensure site compliance, working with quality, operations, and global regulatory affairs teams.

Skills & Requirements

Must-have

  • Conduct internal audits
  • Prepare regulatory documentation
  • Evaluate regulatory impact
  • Implement corrective actions
  • Coordinate with global teams
  • Train site teams on regulations

Nice-to-have

  • Ambitious for patients
  • Accountable for impact
  • Doing the right thing
  • Foster employee development

Key Requirements

  • Master's degree or equivalent
  • Minimum 3 years experience
  • Experience in audits or regulatory dossiers
  • Fluent French, good technical English
  • Knowledge of GMP and EU/French regulations

Work Rights

Not specified

Tailored Resume

Cover Letter