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Outras áreas do setor Farmacêutico

itália
Regulatory Affairs (Junior) Manager, ProductLife Group, in Lombardy, Italy (12/06/2020)

Main responsibilities

  • 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 

Skills

  • Expert in regulatory affairs and promotional materials 
  • Experience in medical devices 
  • Knowledge of Italian and EU registrations 

Education and Experience

  • 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 

Other

  • Fluent in English and Italian for daily contacts 
  • Good communication skills