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Innovation
Consulting

About the job

To develop a new project we are looking for a regulatory affairs Specialist to contribute to the regulatory activities performed on the Eastern RA hub.

About us

Group 10
Responsibilities

  • Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
  • Support the team to gain regulatory approval
  • Liaise with external regulatory authorities as required
  • Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
  • Contribute to data entry in PLG tools enabling measurements of KPI and metrics for regulatory services supplied by the platform/hub
  • Contribute to the production of client administrative documents and reports to be included in regulatory submissions

Group 11
Education

  • Life Sciences related fields (Bachelor’s or higher graduate degree in a science related field)

Group 12
Experience

  • At least 5 years experience minimum in RA in Pharmaceutical Industry or Service Provider – Russian /Eurasia regulation and Russian GMP certification process
  • Experience in UA regulation is a plus
  • Experience in creation dossier and writing SmPC

Group 13
Skills

  • Good knowledge of regulatory procedures
  • Process oriented
  • Ability to work well within a team
  • Excellent organizational and interpersonal skills
  • Fluent in English and Russian language for daily contacts with local and international partners
  • Knowledge of EDMS, Regulatory Databases (Register)
  • Knowledge of RU regulations and/or CIS
  • Ability to work on several activities or projects concomitantly
  • Organisation, Rigor
  • Team player

Regulatory Affairs Specialist

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