About the job

To maintain ongoing exciting projects, we are currently seeking a highly motivated and experienced Regulatory Affairs Specialist to join our local RA teams in Ukraine.

About us

Group 10

  • Drive the preparation of documents for national submissions in Ukraine, both for new Marketing Authorisation Applications (MAA) or for post-MAA activities (LifeCycle Management).
  • Preparation and submission of documentation for post-approval applications (LifeCycle Management) including, but not limited to, Type IA, Type IB, Type II and MAH Transfers/Change of Ownership (COAs)
  • Preparation and submission of Technical/Site Transfer Applications
  • Assisting with the preparation of Marketing Authorisation Applications
  • Assisting with license applications as required
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Ensuring compliance with the regulations of the SEC
  • Use a variety of software packages (Microsoft Office Suite, Veeva or comparable EDMS, LorenZ, Trackwise etc) to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data
  • General regulatory administration duties and compliance requirements
  • Management of artwork generation
  • Ensuring compliance with all regulatory processes, in readiness for both internal and external audits
  • Providing support during external and unannounced audits.
  • Responding to internal requests for technical and/or regulatory information.

Group 11

  • Bachelor’s degree in a relevant Life Science discipline

Group 12

  • At least 5 years of experience in Regulatory Affairs (RA) on the Ukrainian market
  • LifeCycle Management (LCM) experience on the Ukrainian market is required

Group 13

  • Ukrainian Native Speaker is required
  • Good English skills are required
  • Deep experience and knowledge of the Ukrainian RA legislation.
  • Good organizational skills
  • Good communication skills
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritize different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work
  • Good IT skills/knowledge

Regulatory Affairs Specialist - 972