Anna Maj

Senior Regulatory Affairs Specialist
Since Dec 2016
Main responsibilities:
- maintainance of MA from antibiotic and neurology portfolio (including submission of variations, preparation, update and translation of PI etc.)
- maintainance of local regulatory databases
- proofreading and verification of artworks (graphical projects for medicinal products) according to regulatory compliance
- preparation of appropiate communication to Polish regulatory authorities (URPLWMiPB, GIF, NIL etc)
- preparation of SOPs, WOW, instructions etc.
- activities connected with promotion of department and team building with organisation Zobacz mniej

Regulatory Affairs Specialist
Sep 2013 –Dec 2016
Main responsibilities:
- coordination of submissions and approvals of variations for products within my portfolio (MRP/DCP, national, centralized, worksharing and grouped variations)
- close cooperation with central functions during the preparation of the dossiers
- preparation of updates and translations of PI (SmPC, PIL, labelling)
- close work with local authorities (URPLWMiPB and GIF)
- cooperation with marketing, medical, reimbursement and quality departments in order to place high quality product on marekt
- preparation of appropriate communication to the regulatory authorities
- taking part in packaging items updates – making sure that the product on the market is up to date with the registered details - artworks proofreading and acceptance accoding to regulatory demands
- knowledge of current local and Eurpean regulatory law

Main resposibilities
• work in laboratory of molecular biology
• microbiological and genetic analyses
• bioinformatic analyses
• preparation of research plans and projects
• preparation of instructions and manuals according to GLP and GMP
• preapration of documents used in drug registration according to FDA and EMEA rules