Posturi disponible

Regulatory Affairs Specialist - fixed-term 1 year

21.3.2019

Job description:

  • Provide support documentation for the new applications in line with the in force European regulations and /or local pharmaceutical laws depending on the submission type and market
  • Ensure that all responses to authorities’ requests are correct, complete and timely submitted
  • Communicate with third parties in order to expedite submissions and ensure regulatory compliance
  • Provide input and advice for local regulatory teams and cross functional teams on relevant regulatory aspects
  • Ensure that accurate and complete information is timely provided to other departments/third parties
  • Inform the relevant functions on the status and progress of assigned projects in order to meet the set objectives, identify potential problems or delays, and possible solutions, as they occur
  • Maintain the current knowledge of applicable legislation within the responsibility area in line with the most up-to-date provisions
  • Ensure that the internal regulatory database and trackers are kept up-to-date
  • Perform regular reviews of the information available in the internal regulatory database

Requirements:

  • Bachelor’s degree required (preferable chemistry, biochemistry, biology, pharmacy)
  • EU procedures experience is highly recommended for this position
  • English language: advanced level, both speaking and writing; good understanding of English professional terminology
  • Computer skills: very good knowledge of MS Office tools
  • Attention to details
  • Ambitious, responsible person
  • Enthusiastic, proactive
  • Teamwork spirit
  • Ability to work effectively without direct supervision and to be able to report succinctly and efficiently
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