Job Title: Regulatory Affairs Specialist
The role has primary responsibility for supporting all local regulatory affairs workflow including preparation of dossiers and applications for new registration and maintain existing products life-cycle as well as applying the pharmacovigilance policy under the supervision by line Manager.
Preparation of dossiers and applications to register new products and maintain existing products life- cycle
Supporting the relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications.
Artwork revision process, i.e. requesting, proof reading, approval and implementation of artwork




Close cooperation with supply chain and marketing department to ensure product launch and marketing materials approval from regulatory perspective.
At least 6 months 1 -year professional experience on similar position or internship in RA Department in pharmaceutical company or national competent authority
Knowledge of pharmaceutical law and the required documentation for pharmaceutical product
All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

📌 Regulatory Specialist and Senior Specialist (Italia)
🏢 Accord Healthcare
📍 Italia