Michelle Gafa Email & Phone Number
Executive Director, Regulatory Affairs @ tranScrip
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Michelle Gafa Location
- Malta
Michelle Gafa Work
- 2024 -now Executive Director, Regulatory Affairs @
- 2023 -2024 Senior Director, Regulatory Affairs @
- 2015 -2023 Managing Consultant @
- 2015 -2023 Managing Consultant @
- 2014 -2015 Pharmaceutical Regulatory Affairs Consultant @ Freelance
- 1999 -2014 Department Manager - Regulatory Affairs @ Actavis (now Teva)
- 2006 -2012 Occasional lecturer @
- 1998 -1999 Senior Product Registration Officer @ Pharmamed (now Teva)
- 1996 -1998 Product Registration Officer @ Pharmamed (now Teva)
- 1995 -1996 Laboratory Officer (Pharmacy) @
- 1994 -1995 Pharmacist @ Government Public Health Laboratory
Michelle Gafa Education
- Henley Business School
Master of Business Administration (MBA)
1998-2002 - L-Università ta' Malta
Bachelor of Pharmacy (Hons.)
1990-1994
Michelle Gafa Skills
- Regulatory Affairs
- Regulatory Requirements
- Pharmaceutical Industry
- CMC Regulatory Affairs
- Dossier Preparation
- Regulatory Guidelines
- Change Control
- Training
- Drug Master File (DMF)
- Response Strategy
- Common Technical Document (CTD)
- Stability Studies
- Generic Drugs
- Project Management
- R&D
- Management
- Solid Oral Dosage Forms
- Specifications
- Pharmacopoeias
- Regulatory Risk Assessment
- Regulatory Intelligence
- Variations
- Dossier Audit
- Certificate of Suitability (CEP)
- Module 3
- Technical Transfers
- Regulatory Submissions
- Leadership
- Quality Overall Summary (QOS)
- European Regulatory Procedures (National, DCP, MRP, CP)
- Product Development
- Active Pharmaceutical Ingredients
- Injectables
- Pharmaceutical Manufacturing
- Injectable
- Life Sciences
- Consulting
- Business Strategy
- Strategic Planning
- Research and Development (R&D)
- Strategy
- Drug Master File Dmf
- Cp
- Dcp
- European Regulatory Procedures National
- Research And Development R&D
- Quality Overall Summary Qos
- Certificate Of Suitability Cep
- Common Technical Document Ctd
- MRP
- Drug Master File
- Common Technical Document
- Certificate of Suitability
- European Regulatory Procedures
- Quality Overall Summary
- Research and Development
Michelle Gafa Summary
- Michelle Gafa, based in Malta, is currently a Executive Director, Regulatory Affairs at tranScrip. Michelle Gafa brings experience from previous roles at tranScrip, Real CMC, Real Regulatory Ltd and Freelance. Michelle Gafa holds a 1998 - 2002 Master of Business Administration (MBA) @ Henley Business School. With a robust skill set that includes Regulatory Affairs, Regulatory Requirements, Pharmaceutical Industry, CMC Regulatory Affairs, Dossier Preparation and more. Michelle Gafa has 2 emails and 1 mobile phone numbers on RocketReach.
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