International regulatory affairs project manager (Italia)

International regulatory affairs project manager (Italia)

01 ago
|
Recordati
|
Italia

01 ago

Recordati

Italia

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life.



Job Purpose The International Regulatory Affairs Project Manager is responsible for collaborating with European and global Health Authorities to secure new product registrations and ensure the ongoing maintenance of existing marketing authorizations. This role acts as a critical link between the company, its subsidiaries, and international partners to ensure compliance with global regulatory standards, particularly within the rare disease and niche market sectors. Key Responsibilities Regulatory Strategy & Dossier Management Lead the preparation, submission, and strategic follow-up of all regulatory filings, including pre‐authorization dossiers (ODDs, IMPD, IND, PIP, NDA, MAA) and post‐authorization lifecycle management (variations, renewals, annual reports, and re‐assessments). Provide high‐level scientific documentation and regulatory support to international subsidiaries and external partners. Monitor and interpret international legislation t

📌 International regulatory affairs project manager (Italia)
🏢 Recordati
📍 Italia

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