Drug Regulatory Affairs expert & consultant

Rx and OTC; CTA, IND, Module 2 documents, Scientific Advice, orphan designation; variations/product maintenance Switzerland

• Medizin
• Medizinforschung
• Naturwissenschaft
• Pharmazie

Pharmacist with long experience in drug development, working in pharmaceutical industry ("big pharma" as well as start-up companies) with focus on Drug Regulatory Affairs.

Project/product management in drug development and drug regulatory affairs; interim regulatory affairs manager

CTA, IMPD, Clinical Trial Directive, IND, CTD, NDA, dossier updates, module 2 documents, Scientific Advice, orphan designation

Country-specific regulatory affairs activities in Switzerland

Medizin, Pflege & Gesundheit
- Medikamente / Diagnostika
- Apotheker
- Medizinische Forschung
- Medizinische Studien / Clinical Trial

Forschung & Wissenschaft
- Biologie / Biotechnologie
- Chemie (allg.)
- Medizin
- Pharmazie (allg.)

Clinical trial applications (CTA), IND, IMPD, scientific advice, briefing book, orphan designation, CTD, Module 2, medical writing, drug development, interim management