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 programme Remote work options #J-18808-Ljbffr

📌 Manager, eu (Italia)
🏢 Experteer Italy
📍 Italia