In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in Ukraine.

Group 10

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

Group 11
Education & Experience

  • Bachelor’s degree or more in a Life Sciences related field.
  • At least 5 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
  • Previous experience in a consulting company would be a plus

Group 13

Hard/Technical skills:

  • Native Ukrainian mandatory along with fluent English
  • Deep knowledge of Ukrainian RA regulation for pharmaceuticals (NCE, Biologicals and Biotech) and Medical Devices
  • Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations)
  • Strong computer skills, including MS Office applications, data and document management systems (Veeva or comparable EDMS, LorenZ, Trackwise, etc)
  • Experience of promotional/non-promotional activities would be an advantage

Soft skills:

  • Excellent organizational skills
  • Effective oral and written communication skills
  • Ability to work well within a team
  • Process oriented with good attention to detail
  • Ability to prioritize different workloads/multi-task
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on the quality of the work
  • Solution-driven

Regulatory Affairs Specialist - 872