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.
The Role
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.
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
The Rewards
A Bit About Us
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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Requisition ID: ((id))
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📌 Regulatory Affairs Specialist (Italia)
🏢 Accord Healthcare
📍 Italia
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