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 a Regulatory Affairs Manager Description of role The 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 Director Key Responsibilities Check 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 Office Ensures compliance, from the regulatory point of view, of the requirements set by national and regional regulations.

Manage the appointment of ISF at regional/local level Communication about ISF activities to regional/national authorities Management 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 aspects Strategic support to product teams on regulatory aspects Professional Expertise Scientific University Degree 3+ years of experience in the role Competencies Regulatory competencies (Local legislation requirements and Scientific Background) Project Management Communication skills Negotiations skills Positive attitude, flexibility and a proactive approach Cross functional awareness English (written and oral)