CMC Specialist – Generic Medicines Lifecycle Management

About the role

The CMC Specialist (Pharmaceutical Lifecycle Group) is responsible for managing Chemistry, Manufacturing and Controls activities for generic medicinal products. The role focuses on lifecycle management, regulatory variation submissions and the preparation and review of dossier modules in line with European and international guidelines.

Key responsibilities

• Draft and review variation submissions for generic products, covering Modules 1, 2 and 3.
• Ensure effective lifecycle management of generic product dossiers.
• Prepare, review and compile regulatory documentation in compliance with applicable guidelines.
• Assess change controls and evaluate their regulatory impact.
• Develop and share regulatory strategies for variations and dossier updates.
• Support both simple and complex regulatory projects and collaborate cross‑functionally to meet submission timelines.
• Maintain accurate documentation in internal systems such as SharePoint.

Required profile

• Degree in Pharmacy or an equivalent scientific discipline.
• 3–5 years of experience in CMC/regulatory affairs.
• Good working proficiency in English and mandatory proficiency in French (speaking, reading, comprehension).

Required skills

• Module 3 writing.
• Variations submission and management.
• Lifecycle management of medicinal products.
• Preparation and review of regulatory documents.
• Familiarity with European and international regulatory guidelines.
• Change‑control assessment.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Experience using SharePoint and document‑management systems.