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Senior Regulatory Affairs Manager (m/w/d) (DE)
[12588]
Regulatory Affairs, CTA, Submission
Positionstitel: Senior Regulatory Affairs Manager (m/w/d) Anstellungsdauer: unbefristet Branche: Biotech Fähigkeiten: Regulatory Affairs, CTA, Submission Idealer Startzeitpunkt: ab sofort Aufgaben: ·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 Qualifikationen: ·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 a steam work and communication skills ·Confident oral and written communication in German and English is required ·Confident use of MS Office applications
- 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
- 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 a steam work and communication skills
- Confident oral and written communication in German and English is required
- Confident use of MS Office applications
Marco Bannier