Regulatory Affairs Analyst (Pharmaceuticals)

Location: Hybrid position based within reasonable travelling distance of Milan, Italy

Salary: €33,000–€49,400 annualized base pay

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life-sciences and healthcare industries.

What you will do

• Support the regulatory lifecycle management of medicinal products on the Italian market.
• Prepare, review, and coordinate regulatory documentation and submissions.
• Support communications and submissions with Italian health authorities.
• Coordinate client requests, deliverables, timelines, and priorities across concurrent projects.
• Assist with marketing authorisation transfers, labelling, CMC activities, promotional materials, and ongoing product maintenance.
• Collaborate with senior Regulatory Affairs colleagues, participate in meetings, escalate risks, and contribute to process improvements.

Requirements

• Bachelor’s or master’s degree in pharmacy, biology, biotechnology, or another relevant life-sciences discipline.
• Approximately two years of relevant Regulatory Affairs experience supporting medicinal products.
• Experience in a pharmaceutical company, CRO, consultancy, or similar regulated environment.
• Knowledge of the Italian regulatory environment, medicinal-product lifecycle activities, and regulatory documentation or submissions.
• Strong planning, organisation, communication, attention-to-detail, and procedure-following skills.
• Fluent Italian and professional working proficiency in English required. Confidence using Microsoft Office and relevant regulatory systems or publishing tools is also required.

Culture & Benefits

• Collaborative Regulatory Affairs environment with exposure to different clients, products, and regulatory activities.
• Support from experienced colleagues with meaningful ownership of day-to-day deliverables and client interactions.
• Hybrid working arrangement combining remote work with office attendance for face-to-face collaboration.
• Fixed-term maternity cover, with duration aligned to the employee’s effective absence period under applicable Italian requirements.