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Outras áreas do setor Farmacêutico
Regulatory Affairs (Junior) Manager, ProductLife Group, in Lombardy, Italy (12/06/2020)
- Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements.
- Gain regulatory authority approval.
- Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
- Provide regulatory support to clients and associate companies.
- Liaise with external regulatory authorities as required.
- Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling.
- Review tasks for, support and mentor Regulatory Affairs Officers and Associates.
- Assist the RA Platform / Hub Leader or a Senior RA consultant in presales:
- Ensure providing technical support to presales
- Ensure adequate technical description of the proposals and support sales for quotation evaluation
- To provide in-house training as required for staff in the Regulatory Affairs group.To contribute to the production of client documents and reports
- To support the Pharmacovigilance group in the production of Regulatory Authority and Ethics Committee documentation
- Expert in regulatory affairs and promotional materials
- Experience in medical devices
- Knowledge of Italian and EU registrations
- Degree in a science related field or equivalent experience
- More than 5 years’ experience in a regulatory affairs department
- Experience should include a proven understanding of the regulatory process and experience in leading a project to successful completion
- Experience in promotional materials review (Medicinal Product, Medical Device)
- Experience in PV would constitute added value
- Fluent in English and Italian for daily contacts
- Good communication skills