Manager Regulatory Affairs and CMC (m/f/d)

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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