AdresseWe 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.
