Senior Manager – Regulatory Affairs (m/f/d)

We are looking for a SENIOR MANAGER – REGULATORY AFFAIRS (M/F/D) YOUR RESPONSIBILITY Predominant geographical focus is EU Preparation and coordination of clinical trial applications (CTA) / amendments and regulatory documents (IMPD, IB, ERA etc.) and liaison with US colleagues for investigational new drug applications (IND) for clinical trials Preparation and coordination of scientific advisory meetings Electronic submission of CTAs /amendments to European Competent Authorities Regulatory notifications at Local Authorities Implementation and maintenance of the Clinical Trials Information System (CTIS) according to the new EU clinical trial regulation (CTR) Update and maintenance of regulatory documents incl. SOPs and archiving Participation in multidisciplinary project teams at the interface to R&D, CMC, (non)clinical development, clinical immune monitoring, and quality assurance Interaction with Competent Authorities in Europe and US Direct report to the Head of Regulatory Affairs YOUR PROFILE Master’s degree in pharmacy, Biology, Immunology, or Chemistry; PhD or Drug Regulatory Affairs qualification preferred 5 years+ professional experience in early clinical drug development; ideally in immuno-oncology Deep knowledge of the regulatory framework in the EU and preferably U.S. Sound knowledge in GxP, ideally focused on ATMP/ gene therapy specific requirements in the EU and US State-of-the-art experience of complex digital submission portals (CESP, CTIS, etc.) and electronic document management systems Very good time and coordination management skills High degree of initiative and flexibility as well as teamwork and communication skills Confident oral and written communication in German and English is required Confident use of MS Office applications YOUR PERSPECTIVE You want to work within and shape a forward-looking and growing company? You are looking for a self-dependent and multilateral job with great scope for design? You want to work in a team with a pleasant working atmosphere and short communication channels? We look forward to receiving your complete application under the reference number RA01! Please do not hesitate to contact Trenton Bruce at t.bruce@medigene.com. We kindly ask recruitment agencies to refrain from contacting Medigene AG. Medigene AG, Human Resources Lochhamer Str. 11, D-82152 Planegg/Martinsried jobs@medigene.com, www.medigene.de Medigene is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. With its scientific expertise, Medigene is working on the development of innovative immunotherapies to enhance T cell activity against solid cancers in fields of high unmet medical need. Medigene’s pipeline includes pre-clinical as well as clinical programs in development.