RA Manager is responsible for the management of all pre and post marketing activities and other regulatory periodic activities.
Prepares the strategy, the technical documentation, performs the submission (through national and EU portals) and follow-up until approval of MRP, DCP, CP and National Procedures for new marketing authorizations, variations, marketing authorization transfers and renewals according to the relevant EU Regulation and national requirements;
Gives support for the fulfillment of post approval requirements at local level (databases update, PI update, artworks revision, contacts with partners on behalf of MAHs);
Gives pre- and post-marketing regulatory consultancies concerning: adherence to Italian regulations (support for educational material approvals, traceability project, optical stickers, texts update according to EU and national requirements, local commercial partner appointment, AIFA identification code and portal access, support for shortage/marketing interruption notifications/ request of importation from abroad, payback procedures, budget/balance process, communications with IT Authorities and relevant services providers, CPP authorizations, collection of official documentation at AIFA, sunset clause exemption requests);
Performs the daily review of communications/regulations circulated by the Italian Authorities / EMA.
Manages the regulatory procedures in coordination with the Client’s team and the contact with Regulatory Authorities together with or on behalf of the client;
Gives support to the Client in the critical evaluation of the appropriate regulatory strategy;
Concerning project management:
• Is the main contact with the client within the assigned projects;
• Performs general project management activities (timelines, deadlines, milestones), including SAL and other internal activities;
• Monitors clients satisfaction within the assigned projects;
• Gives support to RPN administrative office for invoice setting and management.
Good knowledge of Italian regulations and codes concerning Italian and European regulatory affairs procedures;
At least 5 years of experience in the regulatory affairs field.
• Very good knowledge of spoken and written English;
• Very good organizational skills.