Michelle Coffey Email
Director, Global Regulatory Affairs, Hospital Business Unit @ Pfizer
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Michelle Coffey Location
- Melbourne, VIC, AU
Michelle Coffey Work
- Director, Global Regulatory Affairs, Hospital Business Unit @ (July 2022 - Present)
- Global Head of Regulatory Affairs and Pre-Clinical @ (June 2019 - July 2022)
- VP Quality and Regulatory Affairs @ (September 2018 - June 2019)
- VP Product Development, Regulatory and Commercial @ (July 2017 - June 2019)
- VP Commercialisation @ (March 2017 - July 2017)
- Senior Director, Regulatory Affairs @ (April 2013 - March 2017)
- Regulatory Affairs Product Manager - Global Pharma Development @ (December 2010 - April 2013)
- Senior Regulatory Affairs Associate @ (March 2008 - November 2010)
- Senior Regulatory Compliance @ (March 2005 - February 2008)
- Regulatory Affairs Manager @ Pinewood Healthcare (January 2001 - March 2005)
- Regulatory Affairs Co-ordinator @ Pinewood Healthcare (August 1999 - December 2001)
Michelle Coffey Education
- The University of Manchester
MSc (Pharmaceutical Science)
2000-2004 - University of Limerick
BSc (Industrial Chemistry)
1995-1997 - Technological University Dublin
Diploma in Chemical Analysis
1992-1995
Michelle Coffey Skills
- Regulatory Strategy
- Regulatory Affairs
- Generics
- Regulatory Submissions
- Regulatory Requirements
- FDA
- GMP
- CAPA
- Pharmacovigilance
- ANDA
- Quality Systems
- 21 CFR Part 11
- Pharmaceuticals
- GLP
- cGMP
- eCTD
- GCP
- GxP
- Change Control
- Compliance
- Document Management
- Quality Assurance
- Analytical Chemistry
- Oncology
- Life Sciences
- Pharmaceutical Industry
- Generic Programming
- Lifesciences
- Strategy
- Technology Transfer
- Quality System
- Validation
- Biopharmaceuticals
- IND
- U.S. Title 21 CFR Part 11 Regulation
- Good Laboratory Practice (GLP)
- European Union
- EMA
- U.S. Food and Drug Administration (FDA)
- u.s. Food and Drug Administration Fda
- Customer Service
- Strategic Planning
- Biotechnology
- Sales
- Business Development
- Good Laboratory Practice Glp
- Small Molecules
- Isi Toolbox
- Biologics
- Maa
- Leadership
- Nees
- Regulatory Operations
- Vaccines
- Dcp
- CMC development
- Management
- Impd
- Good Laboratory Practice
- u.s. Food and Drug Administration
Michelle Coffey Summary
- Michelle Coffey, based in Melbourne, VIC, AU, is currently a Director, Global Regulatory Affairs, Hospital Business Unit at Pfizer. Michelle Coffey brings experience from previous roles at Paradigm Biopharmaceuticals and IDT Australia Limited. Michelle Coffey holds a 2000 - 2004 MSc in Pharmaceutical Science @ The University of Manchester. With a robust skill set that includes Regulatory Strategy, Regulatory Affairs, Generics, Regulatory Submissions, Regulatory Requirements and more. Michelle Coffey has 3 emails on RocketReach.
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