Job expirat
-Provide risk evaluation of NPD, EPD projects for local business , headquarter
-Preparation and submission of application forms, new dossiers/variations/renewal applications to local Health Authority
-Negotiate with local Authority on regulatory issues especially new dossiers/variations
-Provide scientific input to NPD dossier development in headquarter
-Provide risk evaluation of NPD, EPD projects for local business , headquarter
-Check supplied dossiers and documents content against local legislation on receipt
-Approve and control all product artwork used locally to comply with national legislation
-Handling renewals, variations as well as new applications processes
-Submit legal classification switch applications to local Health Authority
-Monitoring of acts and decrees of Polish and Baltics pharma laws as well as EU guidelines that influencing on registration operations in the region
-Control all promotional materials used locally to comply with national legislation
-Maintain local and headquarters databases
-Receive, interpret, record and follow up reported product quality and safety issues from consumers and HCPs
-Handle compensation claims and expectation of customers
-Provide feedback to marketing and quality departments for products enhancement
-Parmaceutical or Medical Degree is pre-requisite
-t leas 2-3 years proven experience in the R & M activities in pharmaceutical companies or Regulatory Authority
-ood knowledge of registration processes and good professional relationships with officials involved
-A thorough working knowledge of the pharmaceutical law and specially all local and EU regulatory requirements.