Posturi disponible

Regulatory Affairs Project Manager New Submissions

14.12.2018

Job description:

  • Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through European procedures (MRP, DCP, CP) or national procedures
  • Coordinate the evaluation of possible regulatory strategies and provide support for preliminary reviews of new projects
  • Provide support documentation for the new applications in line with the in force 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 to expedite submissions and ensure regulatory compliance
  • Ensure that all the additional processes related to national submissions are submitted on time and that their submission/approval process does not delay the application
  • Ensure that accurate and complete information is timely provided to other departments/third parties
  • Coordinate the arrangements for inspections required by the local authorities
  • Inform the relevant functions on the status and progress of assigned projects 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:

  • Chemist/ Biologist/Biochemist/Pharmacist
  • 3 – 5 years Regulatory Affairs experience
  • English language: advanced level, both speaking and writing
  • Experience on EU submissions or other regions represent an advantage
  • Ability to work effectively without direct supervision and to be able to report succinctly and efficiently
  • Computer skills: very good knowledge of MS Office tools
  • Attention to details
  • Ambitious, responsible person
  • Enthusiastic, proactive
  • Teamwork spirit, also able to perform alone
  • Analytical thinking, problem solving capacity
  • Well organized
  • Good communication skills
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