Christian has been with NDA since 2008, with over 25 years of global clinical & regulatory experience. He applies his detailed knowledge of legislation, guidance and procedures to successfully support companies throughout their clinical development and the complex EU and US MAA/NDA/BLA marketing authorisation procedures.
Key Areas Of Expertise
- Comprehensive knowledge of regulatory requirements and procedures (NDA, MAA, CTA, PIP, ODD, scientific advice).
- Broad regulatory affairs experience in supporting early to late-stage clinical development with a focus on clinical development strategy, efficacy, safety and benefit/risk assessments
- Track record of successful co-ordination of the operational execution of clinical modules for EU submissions as part of complex multidisciplinary teams
- Evaluation of clinical packages for chances of success in EU regulatory reviews
- Track record of successfully advising and leading clients teams in the generation of response documents during major EU submissions
- Inception, coordination and content review of clinical regulatory documents e.g. IB, IMPD, CTD, Briefing packages, modules 2.5 , 2.7.3 and 2.7.4 for global regulatory dossiers
Christian spent 10+ years in the pharmaceutical industry in roles of increasing responsibility in regulatory affairs, drug safety and R&D Project Management, formerly the head of project management for a European therapeutic business unit of a global pharmaceutical company.