Regulatory Affairs Specialist - Italian & EU

Alfasigma; Lazio; Hybrid; EUR 45,000 - 70,000; Full time

Job summary

Alfasigma is seeking a Regulatory Affairs Specialist to manage local Italian product regulatory activities for Rx and OTC lines. You will prepare and submit dossiers, variations, and renewals while maintaining high data quality and regulatory compliance.

You will collaborate with Quality, Medical Affairs, Market Access and Regulatory teams to navigate EU/Italy guidelines, support promotional material reviews, and monitor regulatory changes for portfolio impact.

Qualifications

• Pharmacy degree and regulatory knowledge required.
• Experience with Italian/EU regulatory processes and dossier preparation.
• Master's in Regulatory Affairs is a plus.

Responsibilities

• Manage regulatory activities for local Italian Rx and OTC products.
• Prepare, review and submit regulatory dossiers (variations, renewals, MA maintenance).
• Interact with AIFA and other Italian regulatory bodies.
• Support development and approval of promotional materials per regulations.
• Collaborate with cross-functional teams to ensure lifecycle management.
• Monitor regulatory changes and propose actions.

Skills

Regulatory knowledge

Regulatory strategy understanding

Attention to detail

Analytical thinking

Communication skills

Team collaboration

English fluency

Education

D.Pharma / Pharmacy degree

Regulatory Affairs Master (plus)

Life sciences degree (Chemistry/Biology)

Tools

eCTD publishing

Veeva RIM

Document management systems

MS Office

Job description

Alfasigma is seeking a Regulatory Affairs Specialist to manage local Italian product regulatory activities for Rx and OTC lines. You will prepare and submit dossiers, variations, and renewals while maintaining high data quality and regulatory compliance.

You will collaborate with Quality, Medical Affairs, Market Access and Regulatory teams to navigate EU/Italy guidelines, support promotional material reviews, and monitor regulatory changes for portfolio impact.