Manager, EU & International Regulatory Affairs – Global Rare Diseases

Chiesi Group

Manager, EU & International Regulatory Affairs developing strategies for global rare disease treatments at Chiesi. Managing regulatory submissions and guiding project compliance with global markets.

Posted 6/13/2026full-timeParma • 🇮🇹 ItalyMid-LevelSenior💰 €46,800 per yearWebsite

About the role

Key responsibilities & impact

develop regulatory strategies for EU & International markets
plan, coordinate and manage regulatory submissions to regional agencies
provide advice and guidance regarding regional regulatory requirements
contribute to the preparation and/or review of submissions to relevant markets
communicate directly with regional regulatory authorities on behalf of Chiesi GRD
review regulatory submission documents, periodic updates, overviews, summaries
develop processes and prepare Standard Operating Documents for GRD Regulatory Affairs
provide regulatory guidance to colleagues from other functional areas
represent the Regulatory Department at the Core Team as a global RA member

Requirements

What you’ll need

3 to 5 years of experience in corporate regulatory affairs roles
in-depth knowledge in the drug development
Life Science Degrees
Flexible, collaborative, open minded
Well-developed written and oral communication and listening skills
Time management skills and demonstrated ability to manage complex assignments
Well-developed analytical and problem-solving skills
Ability to work independently and as part of a team

Benefits

Comp & perks

pension
private medical insurance
wellbeing programme
flexible benefits programme

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategiesregulatory submissionsregulatory requirementsStandard Operating Documentsdrug development

Soft Skills

collaborativeopen mindedwritten communicationoral communicationlistening skillstime managementanalytical skillsproblem-solving skillsindependent workteamwork

Certifications

Life Science Degrees