Rainer has been with NDA since 2007. He provides strategical and operational support to our clients from early development stage to global registration campaigns. He has successfully worked with both small biotech companies and Top 20 global players.
Rainer provides expert support for clients going through Project Orbis. Project Orbis is an initiative of the FDA providing a framework for concurrent submission and review of innovative oncology products among international partners from Australia, Brazil, Canada, Singapore, Switzerland, UK and USA.
Key Areas Of Expertise
- Regulatory strategy advice and project management (CP, MRP, DCP)
- Coordination of Project Orbis
- Preparation / Coordination of Scientific Advice and Pre-Submission Meetings with the EMA and National European Health Authorities
- Preparation / coordination of ODD applications
- Regulatory project management, preparation and submission of new marketing authorization applications (EU, GB, CH, CAN, ORBIS)
- Coordination of merger related regulatory activities
- Maintenance of marketing authorization (CP, MRP, DCP)
- Preparation / coordination of PIP applications
Rainer joined the industry more than 20 years ago, he was lab head for early target validation in endocrinology at Schering AG. Followed by positions as Group Leader Microarrays and Expression Profiling and Project Manager Neuroscience in a biotech company.
He and has been working in regulatory affairs functions since 2006.
Rainer holds a PhD in Cellular Biology and a Master of Drug Regulatory Affairs.
Dr Rainer Paffenholz