Regulatory Affairs Maintenance Officer

regulatory affairs - medical - pharmacy

Nivel cariera

Middle (2-5 ani), Entry (0-2 ani)

Limbi vorbite

engleză

Adresa/ adresele jobului

București


 Job description (main tasks):

  • Initiate, coordinate and supervise the variations for medicinal products from the company portfolio through European procedures (MRP, DCP, CP) or national procedure
  • Coordinate and supervise the renewal of medicinal products from the company portfolio through European procedures (MRP, DCP, CP) or national procedure
  • Provide support documentation for the variations and renewals 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
  • Create and update Global Product Information (PI), as part of the Global PI activities

Candidate Requirements:

  • Ideally, 1-2 years’ experience in Regulatory Affairs/pharmaceutical industry (Life Cycle would represent an advantage)
  • Ability to work effectively without direct supervision and to be able to report succinctly and efficiently
  • English language: advanced level, both speaking and writing; good understanding of English medical terms
  • Computer skills: very good knowledge of MS Office tools
  • Attention to details
  • Ambitious, responsible person
  • Enthusiastic, proactive
  • Teamwork spirit