Functional Skills

Product Strategy
Financial Due Diligence
Compliance and risk
Program Management
Industry Expertise

Software Skills

Adobe Creative Cloud
Microsoft Project
Microsoft Office

Certifications

PMPProject Management Professional

Sector Experience

Manufacturing
Technology
Life Sciences & Pharma

Languages

German
32
years

Years of Experience

4/21

Member Since


Experience

 
Bridging Science to Health,LLC Other
President of Regulatory, Drug Development & Compliance
09/2008 - Present
Main regulatory strategist and writer for international and FDA regulatory submissions
Consultant for multiple large pharmaceutical, biotech, chemical, and OTC companies
CMC Post Marketing Support including risk assessment and gap analysis
Project Manager for CMC, for drug substances/drug products for process and analytical development, product registration and market launch, diagnostics and formulation•• Provides successful strategic regulatory/quality development plans

CMAC, LLC. Other
Independent Consultant for Regulatory/Quality Systems, Project Management
05/1992 - 08/2008
Reviewed and compiled the CMC sections of the INDs and CTX submission for three cardiovascular drugs Senior Regulatory Affairs Consultant for all regulatory submissions, Image Solutions, Inc Successful submission and approval of FDA and EU clinical regulatory filings and subsequent IND updates, annual reports and additional support documentation for biologics, pharmaceutical drugs and medical devices Interfaced with the FDA including pre-IND meetings, End of Phase 2, Pre-NDA, CTD/NDA filings