Manager RAC

---base:meta-keywords:meta-viewport: width=device-width, initial-scale=1.0title: Manager RAC (Regulatory Affairs and CMC) (m/w/d)--- Manager RAC (Regulatory Affairs and CMC) (m/w/d)================================================We are offering a new challenge as Manager RAC (Regulatory Affairs \& CMC) at our site in , Switzerland. You will be a member of the corporate RAC and part of local Swiss regulatory affairs and CMC team dedicated to Drug Substance Business Unit. You will support customer activities focusing on Chemistry Manufacturing and Controls (CMC) for small molecules project mainly and ADCs/Bioconjugates derivatives. In this very dynamic and hands\-on role, you will work collaboratively with the other departments to coordinate the regulatory activities from clinical development up to market launch and life cycle management. You will provide regulatory support/advice internally and to external customer projects related. ** Your responsibilities:** * Authoring/reviewing and maintaining registration documents (Drug Substance CMC Quality Module / sections for INDs, IMPDs, MAAs and/or BLAs) 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 small molecules drug substance)* Managing accreditation in Japan* 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** Your profile:** * Master / Engineering or Ph.D degree in Chemistry, Pharmacy or equivalent scientific discipline* understanding of regulatory affairs for Drug Substance with a strong focus on CMC development for small molecules (traditional CMC development versus accelerated development program) \- You have expertise in...

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