Regulatory Affairs-Expert

PURPOSE OF THE ROLE
Support the Regulatory Operations to ensure the registration and the lifecycle management of the assigned products and countries, according to the specific regulatory requirements.

MAIN AREA OF RESPONSABILITIES OF THE ROLE 

• Support the preparation of the submission dossier, for the assigned products and countries, coordinating the assembly and following all the steps until approval;
• Support the lifecycle management of the assigned products and territory (i.e marketing Authorisation application, renewals of registrations, extensions, variations);
• Support the responsible of the Therapeutic Area for the management of Labelling and Artworks for the assigned products and countries;
• Support the Line Manager in the interactions with other company functions;
• Be constantly updated on the regulatory laws/guidelines and verify/apply the correct legislation in the managed processes;
• Ensure the update of the RIM system for the assigned submissions;
• Ensure the storage of all documents, according to the defined flow;

EDUCATION 

• University Degree in any field of science;

FURTHER REQUIREMENTS

• Italian and english (fluently)

Technical Expertise:

• Knowledge of basic IT application and excellent knowledge of Office(Word, Excel, Power Point);

Will be considered a plus:

• Previous experience in Regulatory Affairs
• Knowledge of Regulatory Information Management system;