Stephanie joined NDA in 2015, as an entrepreneur and founder of the Swiss office. She has strong leadership, strategic thinking, influence management and cross-functional teamwork skills, gained over many years of experience working across therapeutic areas, throughout phases of development including commercialization and conduct of due diligence.
Key Areas Of Expertise
Extensive experience in designing and executing regulatory strategies in several markets (EU / US / Global, including Project Orbis)
- Early and late-stage development of small molecules, biological, orphan and non-orphan medicinal products
- Regulatory roadmaps
- Set up new business areas e.g. international filings in China, Canada, Australia, Singapore
- Lead due diligence
- Engage with Health Authorities around the globe
- Act as a legal representative for clinical trials in Switzerland
- Strategically advise and operationally submit Swiss MAAs submission including life cycle management
- Setting up the required quality management system in Switzerland
- Overseeing and advising a team of regulatory professionals from early to late-stage development/marketing
- Coach for Startup Companies
Stephanie held EU, US and Global Regulatory Affairs positions at F. Hoffmann-La Roche Ltd, Roche Inc, Cytos Biotechnology AG. Gaining 18-years experience across all stages of product development and life cycle management in renal, gastrointestinal, hematological, metabolic disorders, CNS and cancer supportive care therapeutic areas.
Stephanie has a degree in Pharmacy and a Dr. rer.medic title from the University of Berlin, Charité University Hospital, Department of Obstetrics and Gynecology.
Topra; Regulatory Affairs 2020 and beyond
Speaker; Introduction to Drug Regulatory Affairs in Switzerland
Dr Stephanie Krumholz