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.
As part of our growth strategy and product portfolio, we are offering at our site in Bubendorf,Switzerland a new challenge as:
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
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!
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.
