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
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.
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