Description

Your responsibilities:

• Reviewing and maintaining registration documents (Drug Substance CMC Quality Module / sections for INDs, IMPDs, BLAs and MAAs) in accordance with the requirements of the authorities and customers requirements as well as international guidelines.
• Assisting with the submission of post-approval change documentation.
• Regulatory assessment in terms of change management (change controls, deviations).
• CMC regulatory support during the entire process and product development from the pre-clinical via the clinical phases to market launch, internally and in relation to customer projects / attending customer meetings and project team meetings.
• Performing a regulatory review of the source documents in support of the CMC documentation.
• Leading and/or conducting project specific CMC regulatory gap analysis as driver for CMC development (mainly ADCs/Bioconjugates portfolio and derivatives).
• Collaboration with the Health Authorities / customers:  preparing briefing documents, answers to questions from authorities on submitted registration documents.
• Regulatory affairs advise and hands-on support internally for improvement and customer oriented regulatory projects.