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

Date added

• ​Your responsibilities:

• Authoring/reviewing and maintaining registration documents (Drug Substance CMC Quality Module / sections for INDs, IMPDs, MAAs and/or BLAs) 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 (mainly small molecules drug substance)
• ​Managing accreditation in Japan
• ​Collaboration with the Health Authorities / customers: preparing briefing documents, answers to questions from authorities on submitted registration documents
• ​Regulatory affairs advise and hands-on support internally for improvement and customer oriented regulatory projects

​Your profile:

• ​Master / Engineering or Ph.D degree in Chemistry, Pharmacy or equivalent scientific discipline
• ​Good understanding of regulatory affairs for Drug Substance with a strong focus on CMC development for small molecules (traditional CMC development versus accelerated development program) - You have expertise in drafting IND/IMPD/MAA regulatory files from scratch ; experience in regulations & accreditation in Japan is an added value
• ​Good knowledge of cGMP regulations
• ​Good knowledge of ICH guidelines and regulatory requirements for Small Molecules
• ​At least 5 years experience in the pharmaceutical industry / GMP environment: several years in a Regulatory Affairs 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, flexible working ‘attitude’
• ​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 working environment with high-quality infrastructure
• ​Flexible working time model with a 40-hour week and the possibility to work from home
• ​Interesting opportunities to expand your professional knowledge
• ​At least 5 weeks of vacation
• ​Contribution to childcare costs
• Travel insurance for private trips
• ​Privately insured in the event of an accident
• ​13th month's salary, with 100% of the social deductions covered by CARBOGEN AMCIS
• ​If the financial year is successful, there is a profit-sharing
  bonus

​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. Thank you for your understanding.