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

Date added

• ​Your responsibilities:
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• 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

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​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
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  ​We look forward to receiving your application!