Overview
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 dynamic and hands-on role, you will work collaboratively with other departments to coordinate 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 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
* Collaboration with the Health Authorities / customers : preparing briefing documents, answers to questions from authorities on submitted registration documents
* Supporting internal non-customer oriented regulatory projects
Your 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 products
* Good knowledge of cGMP regulations
* Good knowledge of ICH guidelines and regulatory requirements for small molecules and biologics
* At least 5 years experience in the pharmaceutical industry : 2+ years in an RA 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
* 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
Your benefits :
* A dynamic work environment with high-quality infrastructure
* Interesting possibilities to develop your professional skills
* Flexible working hours for a 40-hour week
* At least 5 weeks of vacation
* Participation in childcare costs
* Travel insurance for private travels
* Private insurance in the event of an accident
* 13th monthly salary is paid out without any social benefits deductions, in addition there is a profit sharing in a successful business year
We look forward to receiving your application!
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