CMC Scientist
The Chemistry, Manufacturing, and Controls (CMC) Scientist role is part of the R&D Operations team at Coripharma. The CMC team focuses on ensuring product quality, consistency, and compliance throughout development and production. We seek a motivated and detail-oriented CMC Scientist to support regulatory submissions, documentation, and compliance activities. This role will work closely with cross-functional teams to ensure accuracy and consistency in CMC documentation, contributing significantly to product development and lifecycle management.
- Provide regulatory support to the R&D and/or QC teams by creating, revising, and justifying development, production, and registration specifications in alignment with current regulatory requirements for target countries.
- Compile dossiers (Module 3 and related Quality Overall Summaries) for submission to regulatory authorities or clients, ensuring they meet all current regulatory standards for marketing authorization applications.
- Engage in meetings related to registration processes or other areas requiring CMC expertise.
- Address inquiries from regulatory authorities or clients about dossier contents.
- Maintain databases and document management systems to enable accurate tracking of CMC data.
- Contribute to process improvements in CMC operations to enhance efficiency and quality.
University degree in Life Sciences, Pharmacy, Medicine, Chemistry, or a related field is preferred.
Basic understanding of regulatory requirements and guidelines (e.g., EMA, ICH) is preferred
Familiarity with regulatory submission processes and documentation is preferred
Excellent written and verbal communication skills.
Ability to work independently and as part of a team
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
Enska
Íslenska
