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

As part of our growth strategy and product portfolio, we are offering a new challenge as Manager RAC (Regulatory Affairs & CMC) at our site in Bubendorf, Switzerland. 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 ADCs/Bioconjugates projects mainly.

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:

• 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.