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
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
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
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