Specialist/Snr Specialist Study Start Up and Regulatory Affairs

Added
9 hours ago
Type
Full time
Salary
Salary not provided

Related skills

documentation regulatory affairs ich-gcp translations study start-up

๐Ÿ“‹ Description

  • Lead and coordinate activities to achieve site initiation readiness.
  • Provide subject matter expertise and ensure regulatory compliance.
  • Act as liaison between internal teams, clients, and external stakeholders.
  • Deliver assigned study start-up and regulatory milestones within scope.
  • Make independent decisions on regulatory processes and documentation approaches.
  • Handle medium-complexity regulatory environments, including multi-country requirements.

๐ŸŽฏ Requirements

  • Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent.
  • Minimum 4 years in pharma/CRO or regulatory body.
  • Good knowledge of ICH GCP and national regulations for territories of competency.
  • Understanding of country-specific SSU/Regulatory delivery in Europe and/or the Americas.

๐ŸŽ Benefits

  • Company information and values focused on collaboration and work-life balance.
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