Olga Stratigopoulou
CMC Supervisor at PharOS Ltd- Claim this Profile
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Bio
Experience
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PharOS Ltd
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Greece
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Pharmaceutical Manufacturing
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100 - 200 Employee
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CMC Supervisor
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Nov 2022 - Present
Supervise, participate and train a team in the Pre Approval CMC tasks:- Dossier compilation - Dossier registration procedure for DCPs/CPs/MRPs- Medicinal product lifecycle- Clients' support
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CMC Specialist
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Apr 2020 - Nov 2022
- Evaluating Information for Compilation of the Registration Dossier- Coordinating actions required in order to meet deadlines- Data evaluation for compliance with EU-ICH Guidelines- Dossier customization- Providing scientific support for the approval of new medicinal products- Communicating regulatory information to multiple departments
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Lamda Laboratories
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Greece
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Supervisor
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Jan 2020 - Apr 2020
- Evaluating Information for Compilation of the Registration Dossier- Coordinating actions required in order to meet deadlines- Liaising with Regulatory Authorities (MHRA, FDA) for Submissions & RFIs- Editing of Risk assessment reports - Providing scientific support for the approval of new medicinal products- Communicating regulatory information to multiple departments
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Regulatory Affairs Officer
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Aug 2015 - Jan 2020
- Preparing documents necessary for application, evaluation and approval by competent Authorities- Keeping up-to-date with international legislation, guidelines and practices - Continuous follow-up of ongoing assigned projects- Collecting, collating and evaluating scientific data from a range of sources
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Pharmacist
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Jul 2013 - Aug 2015
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Education
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National & Kapodistrian University of Athens
Master's degree, Industrial Pharmacy -
National & Kapodistrian University of Athens
Bachelor's degree, Pharmacy