Manager Regulatory Affairs and CMC (m/w/d)
As part of our growth strategy and product portfolio, we are offering a new challenge as Manager RAC (Regulatory Affairs & CMC) at our site in Bubendorf, Switzerland. You will be a member of the local regulatory affairs and CMC team dedicated to Drug Substance and ADCs/Bioconjugates Business Unit and will support customer activities focusing on Chemistry Manufacturing and Controls (CMC) for ADCs/Bioconjugates projects mainly. 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:
* 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.
Your profile:
* Master / Engineering or Ph.D. degree in Biochemistry/Biology, Pharmacy or equivalent scientific discipline.
* Good understanding of regulatory affairs for Drug Substance with a focus on CMC development for Biologics - You have expertise in drafting IND/IMPD/MAA/BLA regulatory files from scratch; experience in CMC regulatory affairs Drug Substance for small molecules is an added value.
* Good knowledge of cGMP regulations.
* Good knowledge of ICH guidelines and regulatory requirements for Biologics and Small Molecules.
* At least 5 years experience in the pharmaceutical industry / GMP environment: several years in a Regulatory Affairs department combined with previous CMC (R&D, Operations, Analytics) function.
* Previous experience in CDMO or working in customer projects is a clear advantage.
* Team oriented, pro‑active/problem‑solving mentality, service‑oriented mindset with flexibility to handle multiple tasks, flexible working attitude.
* Good coordination and communication skills – Fluency in English required; Basic knowledge German is recommended.
* Good sense of responsibility and reliability. Knowledge of eCTD submission software (Docubridge) is an advantage.
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