Regulatory Affairs Manger Milano

Regulatory Affairs Manger
Milano
Lombardia, Milano

Our client is a global biopharmaceutical company contributing to people's health worldwide.

For the Italian affiliate (based in Milan) we are looking for aRegulatory Affairs Manager Description of roleThe Regulatory Manager is responsible for the coordination and control of regulatory activities in order to ensure compliance with the National/local Regulations.

He/she ensures a regular updating on the new National/Local regulatory aspects and maintains relations with the competent authorities and Head Office for everything concerning regulatory aspects.

Works in collaboration with the different departments and reports to the Regulatory DirectorKey ResponsibilitiesCheck and approve the promotional/disease awareness materials proposed by Marketing/ Medical/Access functions. Check and approve the artworks (PIL, Primary and secondary packaging) sent by Head Office. QC Linguistic review of PI sent by Head OfficeEnsures compliance, from the regulatory point of view, of the requirements set by national and regional regulations. Manage the appointment of ISF at regional/local levelCommunication about ISF activities to regional/national authoritiesManagement of database maintenance such as CODIFA, Farmastampati / Farmadati, Unifarm etc. Monitoring of Agencies website (AIFA, EMA…)Ensure constant updating regarding new national regulations in the regulatory field. Interact with the competent authorities for all regulatory aspectsStrategic support to product teams on regulatory aspectsProfessional ExpertiseScientific University Degree3+ years of experience in the roleCompetencies Regulatory competencies (Local legislation requirements and Scientific Background)Project ManagementCommunication skillsNegotiations skillsPositive attitude, flexibility and a proactive approachCross functional awarenessEnglish (written and oral)