Experience

Interchemie Werken De Adelaar Eesti AS

• Estonia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Apr 2019 - Present

  Veterinary medicinal product registration according to EU legislation - new Marketing Authorisations - generic applicants, variations, renewals. Compilation of the Registration Dossiers (Part I-IV, SPC/PIL, Quality, Safety, Efficacy Summaries). Compilation of manufacturing process validation reports. Internal audits. Biocidal products registration. Veterinary medicinal product registration according to EU legislation - new Marketing Authorisations - generic applicants, variations, renewals. Compilation of the Registration Dossiers (Part I-IV, SPC/PIL, Quality, Safety, Efficacy Summaries). Compilation of manufacturing process validation reports. Internal audits. Biocidal products registration.



PharmaEstica Manufacturing OÜ

• Tallinn, Estonia

• QPPV/Regulatory Affairs

  • Nov 2010 - 2019

  Maintenance of Parmacovigilance system. Keeping information contained in a Pharmacovigilance System Master File (PSMF) up-to-date. Preparation of Risk Management Plan (RMP) and periodic safety update reports (PSURs). Routine pharmacovigilance activities. Prepare CTD dossiers and other concerned documents for new products, for variations and renewals. Compile eCTDs. Submission of applications via CESP. Updating patient information leaflets (PIL-s), summary of product characteristics (SPC-s) and packages. Update of SOP-s. Training of new employees.



Ülikooli Apteek OÜ

• Tallinn, Estonia

• Pharmacy Manager

  • 2007 - 2010



Terve Pere Apteek OÜ

• Tallinn, Estonia

• Pharmacist

  • 1999 - 2007