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Job Description: CMC Specialist (PLG) Position Summary

The CMC Specialist (Pharmaceutical Lifecycle Group - PLG) is responsible for managing Chemistry, Manufacturing, and Controls (CMC) activities related to generic medicinal products. The role focuses on lifecycle management, regulatory variation submissions, and the preparation and review of dossier modules (Modules 1, 2, and 3), ensuring compliance with European and international regulatory guidelines.

Key Responsibilities

* Perform variations review and drafting for generic products, including:
* Module 1 (Administrative information)
* Module 2 (Quality Overall Summary)
* Module 3 (Quality documentation)

* Ensure effective lifecycle management of generic medicinal product dossiers.
* Prepare, review, and compile regulatory documentation in compliance with applicable guidelines.
* Assess and evaluate change controls and their regulatory impact.
* Provide and share regulatory strategies for variations and dossier updates.
* Ensure compliance with European and international regulatory requirements.
* Support both simple and complex regulatory projects.
* Collaborate cross-functionally to ensure timely and compliant submissions.
* Maintain accurate documentation within internal systems (e.g., SharePoint and document management tools).

Required Qualifications Education

* Degree in Pharmacy or equivalent scientific discipline.

Experience

* Minimum 3 to 5 years of relevant experience in CMC/regulatory affairs.

Required Skills & Competencies Technical Skills

* Strong knowledge of:
* Module 3 writing
* Variations submission and management
* Lifecycle management of medicinal products

* Experience in preparing and reviewing regulatory documents
* Familiarity with European and international regulatory guidelines
* Ability to assess change controls
* Proficiency in IT tools:
* Microsoft Office (Word, Excel, PowerPoint)
* SharePoint and document management systems

Languages

* English: Good working proficiency
* French: Mandatory (speaking, reading, and comprehension)

Soft Skills

* Strong communication skills
* Excellent organizational skills
* Ability to manage multiple priorities effectively

Preferred Qualifications (Nice to Have)

* Proven experience in lifecycle management of generic medicine MA dossiers
* Strong team spirit and collaboration mindset
* Experience in handling complex regulatory projects