Dimitra Koutsomitrou

Experience

• 

  Tutorial Schools

  Jan 2009 - Jan 2010

  Secondary Education Biology Professor

  -Professor of high school biology

• 

  Hellenic Statistical Authority (EL. STAT)

  Jan 2010 - Jan 2011

  Sector Manager

  • Acquisition and analysis of demographic data• Team leader and workload assignment of a 6-person team

• 

  Cryobanks International, Athens

  Jan 2010 - Jan 2010

  Biologist

  Lab staff-cryopreservation of stem cells, derived by cord blood and umbilical cord.

• 

  FARMASYN S.A.

  Jan 2011 - Jan 2015

  Regulatory Affairs and Pharmacovigilance Manager

  - Regulatory Affairs - Communication with local and European authorities - DCP-MRP-National Registration Procedures- Deputy EU QPPV / Training in Pharmacovigilance - Medical advice- Pricing of generics - Business development

• 

  Omega Pharma

  Jan 2015 - Jan 2021

  Regulatory Affairs• Preparing submissions of dossiers for initial MAA, renewals, variations to the National Competent Authorities (NCAs) • Analyzing the RA information: providing support for drafting the regulatory intelligence in both territories, EL & CY for OTC products, medical devices, food supplements, cosmetics, biocides.• Processing Pricing Bulletin and submission of price application files to NCAs• Completing the process for customs clearance • Recording the monthly sales on EOF’s portal• Ordering and reporting to EOF the authenticity labels• Managing & controlling the data housekeeping • Keeping abreast of European and National legislation • Specifying storage, labeling and packaging requirements• Providing information to end-users • Reviewing company practices and providing advice on changes to the system• Reviewing product labeling / product marketing literature for regulatory compliance and claims support for all product categories. This includes close collaboration with marketing force.• Creating and controlling barcodes for repackaging. Main contact with GS1Quality Assurance & Vigilance• Developing & Implementing all necessary standard operating procedures and systems to ensure the effective monitoring of quality & safety standards in accordance with legislation• Investigating the root cause(s) of and ensuring corrective / preventative actions to reduce non conformances• Recording & reporting of customers and end-users quality complaints, vigilance reporting• Supporting the manager to external audits Λιγότερα

  • Senior Associate Regulatory Affairs, Quality Assurance & Safety Surveillance

    Jan 2018 - Jan 2021

  • Regulatory Affairs and Quality Assurance Officer

    Jan 2015 - Jan 2018
• 

  Perrigo Company plc

  Jan 2021 - now

  • Project Manager International Regulatory Affairs

    Jan 2023 - now

  • Senior Associate International Regulatory Affairs

    Jan 2021 - Jan 2023