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 Biologics and Chemistry projects. 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 (DMFs, Drug Substance CMC Quality Module / sections for INDs, IMPDs, NDAs, BLAs and MAAs) in accordance with the requirements of the authorities and customers requirements as well as international guidelinesAssisting 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 meetingsPerforming a regulatory review of the source documents in support of the CMC documentationLeading and/or conducting project specific CMC regulatory gap analysis as driver for CMC developmentCollaboration with the Health Authorities / customers: preparing briefing documents, answers to questions from authorities on submitted registration documentsSupporting internal non-customer oriented regulatory projectsYour profile:Master / Engineering or Ph. D degree in Biochemistry, Chemistry, Pharmacy or equivalent scientific discipline Good understanding of regulatory affairs for drug substance with a focus on CMC development for Biologics and/or Chemical productsGood knowledge of c GMP regulationsGood knowledge of ICH guidelines and regulatory requirements for small molecules and biologicsAt least 5 years experience in the pharmaceutical industry: 2+ years in an RA department combined with previous CMC (R&D, Operations, Analytics) functionPrevious experience in CDMO or working in customer projects is a clear advantageTeam oriented, pro-active / problem-solving mentality, service-oriented mindset with flexibility to handle multiple tasksGood coordination and communication skills – Fluency in English required; Basic knowledge German is recommendedGood sense of responsibility and reliability Knowledge of e CTD submission software (Docubridge) is an advantage Your benefits:A dynamic work environment with high-quality infrastructureInteresting possibilities to develop your professional skillsFlexible working hours for a 40-hour week At least 5 weeks of vacationParticipation in childcare costsTravel insurance for private travelsPrivate insurance in the event of an accident13th monthly salary is paid out without any social benefits deductions, in addition there is a profit sharing in a successful business yearWe look forward to receiving your application! Note for recruitment agencies: We do not accept unsolicited applications from recruitment agencies for this position. Unsolicited applications from recruitment agencies will be deleted and not be processed further. jid60af4c4je jit0938je jiy25je