Position Summary

ProductLife Group is looking for a CMC Specialist to support regulatory activities related to generic medicinal products. The successful candidate will be responsible for managing CMC documentation, reviewing and drafting regulatory variations, and supporting lifecycle management activities in compliance with European and international regulatory requirements.

Key Responsibilities

The CMC Specialist will be responsible for reviewing and drafting regulatory variations for generic products, including Modules 1, 2 and 3 of the regulatory dossier, with a particular focus on Module 3 – Quality documentation. The role includes preparing, reviewing and compiling regulatory documents, ensuring that all submissions are compliant with applicable guidelines.

The candidate will also assess change controls and evaluate their regulatory impact, provide regulatory strategies for dossier updates and variations, and support both simple and complex regulatory projects. The role requires close collaboration with internal teams to ensure timely, accurate and compliant submissions.

The CMC Specialist will also be expected to maintain accurate documentation in internal systems such as SharePoint and other document management tools.

Required Qualifications

The ideal candidate should have a degree in Pharmacy or an equivalent scientific discipline, with at least 3 to 5 years of experience in CMC or Regulatory Affairs within the pharmaceutical industry.

Required Skills

The candidate should have strong knowledge of Module 3 writing, variations submission and management, lifecycle management of medicinal product dossiers, and regulatory documentation. A good understanding of European and international regulatory guidelines is required, as well as the ability to assess change controls and their impact on regulatory submissions.

Proficiency in Microsoft Office tools, SharePoint and document management systems is also expected.

Languages

French is mandatory, including speaking, reading and comprehension. A good working proficiency in English is also required.

Soft Skills

The ideal candidate should have strong communication skills, excellent organizational abilities, and the capacity to manage multiple priorities effectively. A collaborative mindset and strong team spirit are also important for this role.

Preferred Qualifications

Experience in lifecycle management of generic medicine Marketing Authorization dossiers and in handling complex regulatory projects would be considered a strong advantage.