Study Start Up and Regulatory Affairs Specialist (2 years plus experience)

Added
10 days ago
Type
Full time
Salary
Salary not provided

Related skills

documentation gcp regulatory affairs regulatory strategy regulatory compliance

๐Ÿ“‹ Description

  • Leads and coordinates all activities related to achieving site initiation readiness
  • Provides subject matter expertise and ensures regulatory compliance
  • Serves as a key liaison between internal teams, clients, and external stakeholders
  • Accountable for delivery of assigned study start-up and regulatory milestones within defined scope
  • Makes independent decisions within assigned scope regarding regulatory processes and documentation
  • Handles medium-complexity regulatory environments, including multi-country requirements where

๐ŸŽฏ Requirements

  • Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and
  • Minimum 2 years within pharmaceutical or CRO industry or Regulatory body
  • Good knowledge of ICH GCP and national regulations for territories of competency
  • Good understanding of specific country requirements pertaining to SSU/Regulatory delivery in
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