The role

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.
Support RA and QA team in:
Preparation of dossiers and applications to register new products and maintain existing products life- cycle
Preparation of parallel import applications for national and central import procedures.
Supporting the relationships with local regulatory authorities to achieve positive outcomes for new product registrations, variations, renewals, notifications.
Submission of Life Cycle Management changes (variations, marketing status, sunset clause, renewals and line extensions)
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.
Maintain and coordinate various local databases.




Close contact with headquarters RA department to prioritize the new procedures and upcoming changes.
Support to Tender Dept. for qualitative related documentation.
Maintenance of RA/QA internal databases and product master data
Support with PQC and MI

The person

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
An understanding of the drug registration and reimbursement procedures
Strong analytical skills
Being well organized and flexible
Excellent knowledge of MS Office, especially Excel
Fluent English (B2 is minimum)

Clearly define any essential or desirable
Qualifications: pharmacy, biotechnology, biology, chemistry or similar.
Certifications or accreditations: Master concerning Regulator

📌 Internship Regulatory Affairs (Milano)
🏢 Accord Healthcare
📍 Milano