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Senior Regulatory Affairs Manager Italy

Permanent / Florence Italy

up to €70000

Senior Regulatory Affairs Manager Italy

An exciting opportunity has arisen with a leading pharmaceutical company for a Senior Regulatory Affairs Manager. This is a permanent position offering a competitive salary plus benefits package which would provide the candidate a great chance to expand their experience.

Role responsibilities:

  • Identify and respond to regulatory and legislative issues that impact the company's ability to approve and maintain its product portfolio.
  • Participate in regulatory policy network and deliver cross-functional communication to convey policy issues and to ensure one voice policies are developed and kept.
  • Support development of the company portfolio and maximises its life-cycle management
  • Interaction with the key decisive Regulatory Agencies.
  • The role also supports the key area of compliance of marketed products through its impact on new legislation and guidelines
  • Develop processes/tools to underpin effective information management in relation to regulatory policy topics, and to provide regular assessment of external regulatory change and give concise communication on its internal application.
  • Take responsibility for assigned regulatory projects; ensure the quality of submitted documentation in line with statutory requirements

Candidate requirements:

  • A Bachelors degree (or higher) in a relevant discipline
  • At least 8 years' experience in pharmaceutical regulatory activities managing major projects.
  • Strong lifecycle management experience
  • You will need a sound knowledge of global drug development processes
  • Excellent communication skills with proven influencing and negotiation abilities.
  • Working within a global organization with cross-functional teams at a local, EU and Global level.
  • Good commercial awareness and knowledge of the therapeutic areas that the company operates within

 

Keywords: affari regolatori, AIFA, EMEA, FDA, regulatory authorities, regulatory affairs

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk. We regard all communication and correspondence as confidential. Full job descriptions are available on request.

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Resourcing Life Science is a specialist recruitment agency, providing career advice and employment opportunities within the Pharmaceutical, Biotechnology, Medical Devices and Clinical Research industries across the globe.

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info@life-science.co.uk

0044 (0) 207 421 0000

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