Regulatory Affairs, Senior Consultant - Pharma & Biotech

Accomplished regulatory affairs professional, +15 years of in-depth experience in development & licensing of medicinal products. Leading positions in biotech & pharma industry (DE, Canada, US); 3 years at EMA. Post-grad MSc in DRA & Health Economics.

• Medizinforschung

In-depth knowledge & experience in global regulatory affairs and drug development.
Excellent team working and cross-cultural communication skills combined with working experience in Europe & North America. Pragmatic and creative problem solving capabilities; able to simultaneously advance multiple projects, according to priority.

• Consulting on regulatory strategy for the development of innovative medicinal products (pharma & biotech)
• Submission strategy for international regulatory filings (CTA/IND, MAA/NDA), advice on agency responses
• Life-cycle management of approved drugs and biologics
• Advice on key regulatory documents such as PIP, RMP and SmPC
• Support in compilation of regulatory applications (e.g. CTA, orphan drug designation, Fast Track, SME etc.)
• Planning of agency interactions including scientific advice meetings, clarification meetings and oral explanations etc.
• Review of and support in preparation of all types of regulatory dossiers and briefing documents