CMC Specialist – Regulatory Affairs for Generic Medicines

About the role

ProductLife Group is seeking a CMC Specialist to support regulatory activities for generic medicinal products. The role involves managing CMC documentation, drafting regulatory variations, and ensuring compliance with European and international guidelines.

Key responsibilities

• Review and draft regulatory variations for generic products, covering Modules 1, 2 and 3 of the dossier, with a focus on Module 3 – Quality documentation.
• Prepare, review and compile regulatory documents to ensure submissions meet applicable guidelines.
• Assess change controls, evaluate their regulatory impact and propose strategies for dossier updates.
• Support both simple and complex regulatory projects, collaborating closely with internal teams.
• Maintain accurate documentation in internal systems such as SharePoint and other document‑management tools.

Required profile

• Degree in Pharmacy or an equivalent scientific discipline.
• 3 to 5 years of experience in CMC or Regulatory Affairs within the pharmaceutical industry.
• Fluent French (speaking, reading, comprehension) and good working proficiency in English.

Required skills

• Module 3 writing and quality documentation.
• Variations submission and management.
• Lifecycle management of medicinal product dossiers.
• Knowledge of European and international regulatory guidelines.
• Assessment of change controls and regulatory impact.
• Proficiency with Microsoft Office tools.
• Experience using SharePoint and document‑management systems.