Federica Ruberti
Senior Regulatory Affairs Specialist @Zambon
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WORK HISTORY
Senior Regulatory Affairs Specialist @Zambon
Bresso, IT
Managing of the CROs/CMOs performing all the necessary process development, manufacturing and analytical activities required for all drug substance and drug product development activities in support of new dossier submission for registration and product lifecycle in collaboration with the other internal stakeholders- Management of the CMC regulatory strategy for the submission and during the review phase by the Health Authorities- Writing and review of protocols and reports in support of regulatory section submissions (Module 3 eCTD)- Design plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations- Writing and/or reviewing Module 3 of eCTD in collaboration with consultants as required; prepare, review CMC regulatory and Quality documents
EDUCATION
Università degli Studi del Piemonte Orientale
2nd Level Master Degree, Regulatory Affairs and Market Access
Università di Pavia
Laurea in Chimica e Tecnologia Farmaceutica (CTF)
SKILLS
ABOUT FEDERICA RUBERTI
Corporate Regulatory Affairs Specialist at Zambon S,p.A. Bresso (since April 2022)Regulatory Affairs Specialist at Regulatech (March 2021 - April 2022)Regulatory Affairs Specialist at Corden Pharma S.p.A.(March 2019 - March 2021)Global Regulatory Affairs Facilities and Equipment Specialist at GSK Vaccines Siena (from July 2018 to March 2018)QC Compliance Specialist at Patheon Monza part of Thermofisher Scientific (from June 2017 to July 2018)2nd Level Master degree in Regulatory Affairs and Market Access (University of Novara)Degree in Chemistry and Pharmaceutical Technologies (Feb 2017, University of Pavia)
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