CARBOGEN AMCIS
Manager Regulatory Affairs and CMC (m/w/d)
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.