2018 -2019 Director of CMC Regulatory Affairs @ Salzman Group
2013 -2018 Regulatory Affairs Manager @
2013 -2013 Regulatory Affairs Manager - Life Cycle Management @ Hospira Australia Pty Ltd
2012 -2013 Regulatory Affairs Manager - Technology Transfer @
1997 -2012 Regulatory Affairs Product Manager @
1995 -1996 Regulatory Affairs Technical Office @
1992 -1994 Laboratory Manager @
1989 -1992 Vendor Assurance Officer @
Helen Sutton Education
Manchester Polytechnic
BSc(Hons) (Applied Chemistry)
1988-1992
The Manchester Metropolitan University
BSc(Hons) (Applied Chemistry)
1988-1992
Helen Sutton Skills
Generics
Pharmaceuticals
Regulatory Requirements
Regulatory Submissions
cGMP
GMP
Regulatory Affairs
GLP
Quality Assurance
FDA
Regulatory Strategy
Documentation
Compliance
ANDA
Coaching
Oncology
Sop
Pharmaceutical Industry
CAPA
eCTD
Generic Programming
Validation
GxP
Technology Transfer
Leadership
Laboratory
Public Speaking
Regulatory
Solutions
Support
Microsoft Office
SQL
Regulatory Activities
Product Development
Standard Operating Procedure Sop
Integration
Standard Operating Procedure
Helen Sutton Summary
Helen Sutton, based in Melbourne, VIC, AU, is currently a Regulatory Affairs Consultant at Global Pharma Solutions. Helen Sutton brings experience from previous roles at Salzman Group, Catalent Pharma Solutions, Hospira Australia Pty Ltd and Hospira. Helen Sutton holds a 1988 - 1992 BSc(Hons) in Applied Chemistry @ Manchester Polytechnic. With a robust skill set that includes Generics, Pharmaceuticals, Regulatory Requirements, Regulatory Submissions, cGMP and more. Helen Sutton has 1 emails on RocketReach.
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