We are a young and dynamic Biopharma company based in the Mannheim area specialized in oncology and looking to grow our team with an experienced Senior RA Manager.
We are a young and dynamic Biopharma company specialized in the development of highly targeted cancer immunotherapies. Using an innovative approach to cancer treatment, we have several products in the pipeline with quite a few coming into Phase III and new developments being launched continuously.
•Lead regulatory strategy and operational implementation of development programs
•Prepare and compile the Common Technical Document (CTD) for dossier submission
•Review and write high-quality Regulatory Affairs documentation
•Build and maintain a sustained liaison with Regulatory Authorities
•Lead preparation and conduct of Regulatory Authority meetings
• 5 or more years of Regulatory Affairs experience in drug development in the biotechnology or pharmaceutical industry environment
• Excellent communication and problem-solving skills
• Ph.D. in natural sciences or equivalent education
• Fluency in German and English
For further details, please call on +49 304 0817 2730 or email directly at email@example.com to discuss in confidence.