Moumita M Email
Regulatory Submission Specialist @ OPIS
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Moumita M Location
- Melbourne, VIC, AU
Moumita M Work
- 2022 -now Regulatory Submission Specialist @
- 2021 -2022 Study Start Up Lead @
- 2020 -2021 Study Start Up and Regulatory Specialist @
- 2020 -2020 Research Governance Officer @
- 2018 -2019 Regulatory Affairs Associate @
- 2017 -2018 Regulatory Compliance Specialist @
- 2016 -2016 Quality Assurance Specialist @
- 2015 -2016 Residential Security Office - Proctor @
- 2012 -2012 ADL Scientist and Trainee @
Moumita M Education
- Northeastern University
Master's Degree
2015-2017 - SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Master’s Degree
2011-2013 - University of Mumbai
Bachelor's Degree
2007-2011
Moumita M Skills
- GMP
- Regulatory Affairs
- HPLC
- Validation
- Medical Devices
- Pharmaceutical Industry
- Quality Assurance
- High-Performance Liquid Chromatography (HPLC)
- Clinical Trials
- Documentation
- Standard Operating Procedure (SOP)
- Good Clinical Practice (GCP)
- Quality Management
- TQM
- Good Laboratory Practice (GLP)
- U.S. Title 21 CFR Part 11 Regulation
- Corrective and Preventive Action (CAPA)
- Scientific Writing
- QSR
- Regulatory Submissions
- ISO 13485
- Microsoft Office
- Microsoft PowerPoint
- Microsoft Excel
- Microsoft Word
- Leadership
- Stability Studies
- Labware LIMS
- Dissolution Testing
- ICH Guidelines
- PMA
- CTD
- NDA
- IDE
- IND
- SOP Authoring
- cGMP practices
- Empower
- Wet Chemistry
- GDMS
- Documentum
- Deviations
- 510(k)
- Electronic Common Technical Document (eCTD)
- Clinical Research Associates
- Clinical Trial Management System (CTMS)
- Informed Consent
Moumita M Summary
- Moumita M, based in Melbourne, VIC, AU, is currently a Regulatory Submission Specialist at OPIS s.r.l.. Moumita M brings experience from previous roles at PRA Health Sciences, Syneos Health Clinical Solutions, Centre for Eye Research Australia (CERA) and Parexel. Moumita M holds a 2015 - 2017 Master's Degree @ Northeastern University. With a robust skill set that includes GMP, Regulatory Affairs, HPLC, Validation, Medical Devices and more. Moumita M has 1 emails on RocketReach.
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