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.

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

Education

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

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

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

Publish Date

26 August, 2021

Spontaneous Application

Regulatory Affairs Specialist

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

Apply