Our client, a Contract Research Organisation (CRO) specialising in early phase clinical development, is seeking a Freelance CMC Regulatory Expert in France to support regulatory strategy and CMC documentation for clinical trial submissions.
Key Responsibilities
- Develop CMC regulatory strategies for early phase clinical trials
- Prepare and review CMC documentation for CTA and IMPD submissions
- Support IND submission documentation where required
- Ensure compliance with EMA, ICH, and French regulatory requirements
- Collaborate with CRO project teams, manufacturing partners, and sponsors
- Support regulatory authority responses and submission lifecycle management
Requirements
- Experience in CMC Regulatory within pharmaceutical, biotech, or CRO environments
- Strong knowledge of EU and French regulatory frameworks
- Experience preparing CTA, IMPD, or IND documentation
- Knowledge of early phase clinical development
Contract Details
- Freelance / Consultant Position
- Location: France (Fully remote)
- Sector: Clinical Research / Early Phase CRO
Apply now to join an early phase CRO supporting innovative clinical development programmes.
