Regulatory Affairs-Expert

PURPOSE OF THE ROLE
Support the Department to ensure the registration and life-cycle management of the assigned products (medicinal products, medical devices, cosmetics, food supplements) in the assigned countries (Albania and Balkans), according to the specific regulatory requirements.
May be the interface with Institutions.

MAIN AREA OF RESPONSABILITIES OF THE ROLE 

• Ensure the preparation of the Dossier for obtaining Marketing Authorizations, for the assigned products and countries, coordinating the assembly and following all the steps until submission;
• Ensure the life cycle management of the assigned products and territory (renewals of registrations, extensions, variations etc.);
• Follow up the procedures from submission till approval;
• Specify the regulatory requirements and support the management of Labeling and Artworks for the assigned products and countries;
• Perform the ''regulatory alerting" concerning products and countries (Albania and Balkans);
• 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 archiving of all documents, according to the defined flow;
• Update the company systems related to Regulatory Information Management;
• Support for the administrative part, the submission to the local authority for pricing, as needed;
• Assist the Line Manager in other activities within regulatory department;
• Support in review and submission to local authorities, when applicable, of promotional materials and other type of materials and follow-up until approval, when applicable;
• Assist in other regulatory compliance activities including regulatory support for Promotion & Scientific Information activities for all product categories of the Dompé portfolio in the concerned countries.

EDUCATION 
University degree - Scientific

FURTHER REQUIREMENTS

• Excellent knowledge of English language;

Technical Expertise:

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

Will be considered a plus:

• Previous experience in Regulatory Affairs
• Knowledge of Regulatory Information Management systems;
• Knowledge of Italian language.