Export Regulatory Affairs Specialist (CTD)

  • Collect and coordinate information and prepare regulatory CTD documentation for submission to regulatory agencies, authorities or to commercial partners.
  • Expertise proficiency with software tools and matrices for CTD submission.
  • Select and prepare CTD for products according to management instructions.
  • Coordinate with the R&D, Q.C, Q.A, Production, Supply chain and Marketing team members regarding the different registration issues and documents required for CTD preparation.
  • Ensure confidentiality in respect of CTD registration files contents.
  • Review carefully compiled CTD files to ensure that content, quality; accuracy and format of submission comply with applicable regulations of different markets.
  • Perform other related duties as assigned.


Skills

  • BSc of pharmaceutical sciences
  • 3-4 years of experience in CTD files preparation is a must
  • Excellent Computer skills
  • Very good command of the English language, read, written and spoken
  • Having good organizational and communication skills
Post date: Today
Publisher: Bayt
Post date: Today
Publisher: Bayt