At Miltenyi Biotec, 3000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases. In the newly created Miltenyi Biomedicine GmbH, a daughter company of Miltenyi Biotec focusing on pharma, we bundle our activities for the development and marketing of cell therapeutics.
- In your role as a Regulatory Affairs Manager you support and maintain the EU-submissions with focus on Clinical Trial Authorization Application.
- This means you prepare, review and submit regulatory documents to national competent authorities (e.g. IMPD, ERA, eCTD etc.).
- In collaboration with internal and external experts you will generate and submit the responses to question for health authorities.
- In cross-functional project teams you will represent the Regulatory Affairs Department and work closely with your colleagues to ensure timely approval of new drug products and maintain marketing authorizations.