Responsibilities: 

  • RA specialist activities for safety variations, renewals and initial filings (new applications) in International countries (Eurasia, Asia, MEA and LatAm) –Good coordination skills for coordinating for the submission files with Headquarters and affiliates
  • Experience with Initial filings in Europe is a plus
  • Excellent organizational and interpersonal skills
  • Ability to work well within a team and share expertise
  • Process orientated with good attention to detail
  • Effective oral and written communication skills
  • Sense of responsibility and meeting deadlines

Qualification

Required experience :

Min 5 years of experience in a regulatory affairs department required and  relevant experience in some International region regulations

Required technical skills :

  • Good computer skills and the ability to learn appropriate software
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel

Required education :

Bachelor’s or higher graduate degree in a science-related field, or equivalent experience.

Regulatory Affairs Specialist - 757