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

Date added

• ​Your responsibilities: ​

• Reviewing and maintaining registration documents (Drug Substance CMC Quality Module / sections for INDs, IMPDs, 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 (mainly ADCs/Bioconjugates portfolio and derivatives).
• ​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 Biochemistry/Biology, Pharmacy or equivalent scientific discipline
• ​Good understanding of regulatory affairs for Drug Substance with a focus on CMC development for Biologics - You have expertise in drafting IND/IMPD/MAA/BLA regulatory files from scratch ; experience in CMC regulatory affairs Drug Substance for small molecules is an added value.
• ​Good knowledge of cGMP regulations
• ​Good knowledge of ICH guidelines and regulatory requirements for Biologics and 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.

​​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.