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 kindly ask recruitment agencies to refrain from contacting Medigene AG.

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