- Department: Regulatory Affairs
- Hours: Full-time
- Location: Bubendorf, Switzerland
-
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 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 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
We look forward to receiving your application!
- CARBOGEN AMCIS is a leading service provider in the area of product and process development, including the commercial production of active ingredients for the pharmaceutical and biopharmaceutical industries. We have 4 facilities across Switzerland (Aarau, Hunzenschwil, Bubendorf, and Vionnaz), as well as locations in St-Beauzire (FR), Manchester (UK), Shanghai (CN) and Veenendaal (NL). Our success is based on the high professional and personal competence of our employees. Learn more about careers opportunities at CARBOGEN AMCIS at: www.carbogen-amcis.com/careers
-
- Hide