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 to ensure compliance with National/local Regulations.
He/she ensures regular updates on new National/Local regulatory aspects and maintains relations with the competent authorities and Head Office for everything concerning regulatory aspects.

Works in collaboration with 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.
Ensure 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.
Communicate ISF activities to regional/national authorities.
Manage database maintenance such as CODIFA, Farmastampati/Farmadati, Unifarm, etc.
Monitor Agencies' websites (AIFA, EMA...).
Ensure constant updating regarding new national regulations in the regulatory field.
Interact with competent authorities for all regulatory aspects.
Provide 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.
Negotiation skills.
Positive attitude, flexibility, and a proactive approach.
Cross-functional awareness.
English (written and oral).
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