Abbreviated Curriculum Vitae
Regulatory Activities
Regulatory Support
- Regulatory strategies for new and marketed products
- Regulatory strategies and plans for clinical studies
- Regulatory research
- Interactions with Regulatory Agencies
- Regulatory advice and guidance during drug development
- Responses to questions from Health Authorities
- Regulatory interim management
Regulatory Documentation
- Clinical studies: CTA/IMPD, IND, CTX
- Dossiers: CTD, MAA, NDA, ANDA, Regional Core Dossiers, Variations, Supplements, Amendments, Annual Reports, Re-registration Applications
- Orphan Designation Applications (EU, US)
- Drug Master Files: EDMF Open and Closed Parts, FDA Type I and Type II
- Clinical Study Reports, ISE, ISS
Training
- Tutoring of entry-level Regulatory Professionals
- Workshop tutorials
Therapeutic and Product Areas
Therapeutic areas
- analgesics / anesthetics
- Anti-infectives / antivirals
- Cardiovascular
- Central Nervous System
- Dental
- Dermatology
- Endocrine
- Oncology
- Pulmonary
Product Areas
- Drugs, combination products
- Branded drugs, generic drugs, orphan drugs, US over-the-counter
- Starting materials, intermediates, drug substances / API
- Drug products: oral preparations (tablet, capsule, modified-release, granules, suspension, solution), sterile injectable preparations
Compliance Activities
- Regulatory Affairs due diligence audits
- Document review for regulatory submissions
Areas of the World
- Australia / New Zealand / Asia
- Canada
- Europe
- Latin America
- South Africa
- USA
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Experience
- President and Principal Consultant
- Jarosz Regulatory Services, Inc.
- Whitewater, WI USA
- Jan 1996 to present
- Senior Regulatory Affairs Associate
- Abbott Laboratories
- Abbott Park, IL USA
- Sept 1994 to Dec 1995
- Regulatory Affairs Associate
- Abbott Laboratories
- Dec 1992 to Sept 1994
- Regulatory Affairs Associate/Label Editor
- Abbott Laboratories
- Feb 1992 to Dec 1992
- Research Pharmacist and Project Leader
- Abbott laboratories
- North Chicago, IL USA
- Sept 1988 to Feb 1992
- Responsible for the development and scale-up of the clarithromycin pediatric formulation (currently marketed internationally and in the USA).
- Clinical Pharmacist
- University of Wisconsin
- Madison, WI
- June 1986 to Aug 1988
- Michael Reese Hospital
- Chicago, IL
- June 1984 to June 1986
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Education
Baccalaureate degree in Pharmacy from the University of Illinois at Chicago (USA), conferred June, 1984.
Professional
Organizations
DIA
RAPS
TOPRA
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