Regulatory Affairs Intern

France

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BlueReg is a consultancy company specialized in Regulatory Affairs in development/registration & maintenance, quality management, pharmaceutical development, writing, publishing and Pharmacovigilance for the Pharmaceutical Industry. Based in Paris, Sophia Antipolis and London, BlueReg has over 100 clients ranging from large multinationals to small start-up companies, from innovators to generic companies. BlueReg was founded in 2011 and, since then, has experienced significant year-on-year growth. In the context of its continued growth, BlueReg Europe is currently seeking a Director, Scientific Writing Drugs & Biologics. This position is based in Sophia Antipolis (South of France) or Paris or London High Wycombe (UK)

Summary

Manages and Leads the Global Scientific Writing Team. Acts as Senior Expert in Regulatory Writing and provides its expertise to customers and to all BlueReg collaborators.
Is a source of Regulatory Writing expertise in the global development, registration and maintenance of pharmaceutical products (drugs and biologics) or other Health care products (medical devices/cosmetics/herbals).
Develops and maintains a network with the professional associations, regulatory agencies and clients. Contributes to the effective functioning and to the business growth of BlueReg in general and BlueReg Europe in particular

Education and experience

  • Completes basic job-related responsibilities e.g. maintenance of personal training record, timesheets, project
  • A least 15 years of experience in the pharmaceutical industry, with a minimum of 8 years in Regulatory Writing at the international level
  • Sound knowledge of ICH & non-ICH pharmaceutical regulations and experienced in cross-functional project

Essential skills and abilities

  • Excellent written and verbal communication skills across multiple levels of an organisation.
  • Established relationships and proven negotiation skills with management, colleagues and
Please send a copy of your CV and a cover letter to rh@blue-reg.com
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