Specialist/Snr Specialist Study Start Up and Regulatory Affairs

Added
1 hour ago
Type
Full time
Salary
Salary not provided

Related skills

documentation regulatory affairs quality control ich-gcp translations

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 study start-up and regulatory milestones within defined scope.
  • Decide on regulatory processes and documentation approaches within scope.
  • Manage medium-complexity regulatory environments and multi-country requirements.

๐ŸŽฏ Requirements

  • Graduate degree in Chemistry or Life Sciences, Nursing or equivalent.
  • Minimum 4 years in pharma/CRO or regulatory body.
  • Strong knowledge of ICH-GCP and national regulations for territories of competency.
  • Understanding of country requirements for SSU/Regulatory in multiple European/Americas regions.

๐ŸŽ Benefits

  • Collaborative, international team with global opportunities.
  • Flexible work arrangements and emphasis on work-life balance.
  • Culture focused on quality, integrity and agility.
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