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Job Description: CMC Specialist (PLG) Position SummaryThe 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
Module 3 (Quality documentation)
Ensure effective lifecycle management of generic medicinal product dossiers.
Required Qualifications Education
Experience
Required Skills & Competencies Technical Skills
Lifecycle management of medicinal products
Experience in preparing and reviewing regulatory documents
Languages
Soft Skills
Preferred Qualifications (Nice to Have)
