Manager, EU

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78dnci

Experteer Overview In this role you will develop regulatory strategies for EU and international markets for Chiesi Global Rare Diseases. You will coordinate regulatory submissions and provide guidance on regional requirements to support product development and expansion. You will negotiate with regulatory authorities, review technical documentation, and contribute to process improvements. This position sits within a global RA function and offers close collaboration with cross‐functional teams to drive reliable regulatory outcomes.
Responsibilities Plan, coordinate and manage regulatory submissions to regional agencies across the life cycle of GRD products
Advise on regional regulatory requirements to drive development and geographical expansion
Prepare and review submissions to ensure high-quality documentation
Interact with regional regulatory authorities to negotiate submission strategies
Review submission documents and recommend improvements for adequacy




Contribute to development of Standard Operating Documents for GRD Regulatory Affairs
Provide regulatory guidance to colleagues from other functions
Support due diligence assessments with regulatory input
Represent Regulatory Department on Core Team as needed
Prepare documents for meetings with regional regulatory authorities
Qualifications 3 to 5 years of experience in corporate regulatory affairs with in‐depth drug development knowledge
Life Science Degrees
Strong written and oral communication and listening skills
Time management and ability to manage complex assignments
Analytical and problem‐solving skills
Ability to work independently and in a team
Benefits Annual premio scheme
Comprehensive pension
Private medical insurance
Wellbeing programme
Flexible benefits programmeRemote work options
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78dnci