Quality Operations Manager @ (September 2016 - May 2022)
Associate Director, Regulatory Affairs and Quality Assurance @ (December 2011 - July 2016)
Associate Director, Medical Information @ CanReg Inc. (April 1998 - December 2011)
Customer Service Representative @ (January 1995 - January 1998)
Irma Monaco Education
Niagara College
Pharmacy Technician (Pharmacy Tech)
1994-1995
McMaster University
Bachelor of Science (Mathematics)
1989-1993
Irma Monaco Skills
Regulatory Affairs
Pharmacovigilance
Excel
Word
Pharmaceuticals
Regulatory Strategy
FDA
Regulatory Submissions
GMP
Regulatory Requirements
CAPA
Validation
Pharmaceutical Industry
Sop
Medical Affairs
Quality Assurance
Strategy
GCP
Clinical Trials
GLP
Microsoft Excel
Microsoft Word
GxP
Pharmaceutics
Change Control
ISO 13485
CRO
Drug Development
Quality System
Biopharmaceuticals
Clinical Development
Life Sciences
Vaccines
Biotechnology
Medical Devices
21 CFR Part 11
Standard Operating Procedure (SOP)
U.S. Food and Drug Administration (FDA)
u.s. Food and Drug Administration Fda
Standard Operating Procedure Sop
Standard Operating Procedure
u.s. Food and Drug Administration
Irma Monaco Summary
Irma Monaco, based in Hamilton, ON, CA, is currently a Senior Manager Regulatory Affairs at Fusion Pharmaceuticals. Irma Monaco brings experience from previous roles at EMD Serono, Inc., Methapharm Inc., CanReg Inc. and Fila. Irma Monaco holds a 1994 - 1995 Pharmacy Technician in Pharmacy Tech @ Niagara College. With a robust skill set that includes Regulatory Affairs, Pharmacovigilance, Excel, Word, Pharmaceuticals and more. Irma Monaco has 2 emails on RocketReach.
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