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Regulatory Affairs (RA) Manager

Application deadline date has been passed for this Job.
Headcount
  • Data publikacji: 6 lutego 2019
  • Aplikacje 0
  • Wyświetleń 1404
Przegląd oferty pracy

RESPONSIBILITIES:

  • Act as RCC (Regulatory Competency Center) manager for region RME: responsible for the interface between RME countries and the RCC on any regulatory request
  • Act as RCC project manager responsible for management of assigned regulatory projects to be delivered according to timelines (confirmation of the regulatory strategy, authoring of documents , coordination with required contributors, compiling, publishing and submitting registration dossiers to competent authorities according to relevant regulatory requirements)
  • Responsible for direct contacts with authorities in RME countries involved in strategic discussion
  • Communication with regulatory agencies, request for information or other procedures / enquiries regarding medicinal products
  • Provide input into final RA budget for next fiscal year (FY)

 

EXPERIENCEAND SKILLS:

  • University degree in medical life science such as pharmacy, biology, (bio)chemistry or equivalent; Ph.D. or Master in Drug Regulatory Affairs or Pharmaceutical Medicine would be an asset
  • Minimum of approx. 5 years of RA experience in a global, matrix based international pharma company covering pre- and postauthorization processes for human medicinal products
  • Solid European pharma regulatory knowledge, experience in MRP/ DCPs/National procedures
  • Be able to work in multicultural team, within virtual team (remote team activities)- strong team player
  • Experienced with eCTD-submission
  • Careful planning to achieve accurate and efficient results driven
  • Process improvement mindset – open-minded
  • Ability to discuss strategy and sensitive (regulatory) issues based on data and current regulatory environment
  • Keep up to date with laws and regulations relevant to product portfolio, market trends and new developments
  • High language skills: Fluent in English, both verbally and in writing
  • Must have computer literacy to operate standard word and excel processing, spreadsheets, presentation and internet applications
  • Scientific knowledge in medical, pharmaceutical area
  • Familiar with principles of medical device development
Dodaj ogłoszenie
  • Oferowane wynagrodzenie 0 - 2000 zł
  • Doświadczeniepowyżej 5 lat
  • WyksztalcenieWyższe
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