reviewing Chemistry, Manufacturing, and Controls (CMC) documentation, and maintaining up-to-date knowledge with project schedules. 2. CMC Writing: Write and review high-quality CMC documentation for regulatory the Common Technical Document (CTD). Ensure that CMC documents are accurate, complete, and compliant with pharmaceutical industry. Demonstrated experience in CMC writing and preparation of regulatory submissions
reviewing Chemistry, Manufacturing, and Controls (CMC) documentation, and maintaining up-to-date knowledge with project schedules. 2. CMC Writing: Write and review high-quality CMC documentation for regulatory the Common Technical Document (CTD). Ensure that CMC documents are accurate, complete, and compliant with pharmaceutical industry. Demonstrated experience in CMC writing and preparation of regulatory submissions
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for variations (CMC & Labelling), Renewals, Artwork updates etc.
/>Responsible for the management of a skill group such as CMC, Regulatory affairs project management, etc.
regulations and guidelines
regulations and guidelines
legislation, regulations and guidelines for variations (CMC & Labelling), Renewals, Artwork updates etc.