Regulatory Affairs Analyst
Core
Support the regulatory lifecycle management of medicinal products on the Italian market, including submissions, documentation, and interactions with health authorities.
Role type
Regulatory Affairs Analyst
Builds
Regulatory submissions and lifecycle maintenance for pharmaceutical products
Domain
Life sciences / Pharmaceutical regulatory affairs
Deliverable
client delivery
Required skills
Regulatory lifecycle management, regulatory documentation preparation, health authority communication, project tracking, process improvement, Microsoft Office, regulatory systems
Preferred skills
Italian regulatory environment knowledge, marketing authorisation transfers, labelling, CMC activities, promotional materials support
Technologies
Microsoft Office, regulatory systems, publishing tools
Responsibilities
Prepare and coordinate regulatory documentation and submissions, support routine communications with Italian health authorities, work with clients to meet regulatory deadlines, assist with lifecycle maintenance and marketing authorisation transfers, track deliverables and priorities across projects, participate in internal and client meetings
Seniority
Early-career, hands-on IC
