Posturi disponible

Regulatory Submission Project Manager


Job description:

  • Initiate, coordinate and supervise the registration of medicinal products from the company portfolio through European procedures (MRP, DCP, CP) or national procedures
  • 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 to expedite submissions and ensure regulatory compliance
  • Ensure that all the additional processes related to national submissions (pre-reviews, DMF, PMF, GMP accreditation etc.) 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
  • Creation and update of the Product Information (PI), irrespective of the source of the request (from authorities, PRAC reports, internal safety signals, etc.)
  • Ensuring prompt support and documents related to the PI
  • On-time support for responses to letters of deficiency in relation to the PI as per deadlines imposed
  • Provide support for samples preparation and dispatch, when necessary
  • 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


  • Chemist/ Biologist/Biochemist/Pharmacist
  • At least 3 years Regulatory Affairs experience
  • EU procedures experience would be an advantage
  • English language: advanced level, both speaking and writing; good understanding of Englishmedical terms
  • Computer skills: very good knowledge of MS Office tools
  • Ability to work effectively without direct supervision and to be able to report succinctly and efficiently
  • Attention to details
  • Ambitious, responsible person
  • Enthusiastic, proactive
  • Teamwork spirit, also able to perform alone
  • Analytical thinking, problem solving capacity
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