Regulatory Affairs Analyst 

The selected candidate will independently manage and support the Project Lead in activities related to the preparation and review of regulatory submissions, including those related to pharmacovigilance and medical-scientific services, for clients and Regulatory Authorities. The role will also involve participation in the development of regulatory and pharmacovigilance projects. 

Responsibilities 

• Support regulatory management for obtaining and maintaining national, MRP/DCP, and centralized registrations in accordance with national and European regulations (New MAAs, Extensions, Renewals, Variations, Transfers of Marketing Authorization, etc.) 

• Review product information (SmPC, PIL, labels) to ensure compliance with Italian and European regulatory requirements 

• Support senior staff in managing relationships with AIFA officials 

• Manage direct communication with client companies 

• Handle activities related to the medical-scientific service: review of promotional materials for medicinal products and preparation of related documentation for submission to AIFA 

• Manage pharmacovigilance activities: collection, coding, and processing of Adverse Events, preparation of CIOMS forms for clients, and quality control of exchanged data 

Requirements 

• Degree in scientific disciplines (Pharmaceutical Chemistry and Technology, Pharmacy, Biology) 

• 1–2 years of experience in Regulatory Affairs departments of pharmaceutical companies or regulatory consultancy firms 

• Knowledge of Italian and European regulatory frameworks and procedures for medicinal products 

• Precision, accuracy, and attention to detail 

• Customer-oriented approach 

• Excellent organizational skills and ability to meet deadlines 

• Ability to work both independently and as part of a team 

• Strong written and verbal communication skills 

• Excellent command of English, both written and spoken and Italian 

Work location: Milan