인재풀 - Country Approval Specialist (ssu)

PPD (Thermo Fisher)

Seoul, South Korea
Hybrid
Country regulatory submission strategy
Ec and moh local applications
Informed consent document development
This position serves as an evergreen talent pool for the second half of 2025 with priority interview access for regular roles

Job Summary

  • This position serves as an evergreen talent pool for the second half of 2025 with priority interview access for regular roles.
  • The role involves managing end-to-end country submissions including EC approvals, gene therapy dossiers, and import licenses in alignment with global strategies.
  • Candidates will act as the primary contact for investigators and local regulatory authorities to ensure timely site activations and compliance with PPD SOPs.

Matching Summary

This position serves as an evergreen talent pool for the second half of 2025 with priority interview access for regular roles.

Skills & Requirements

Must-have

  • Country regulatory submission strategy
  • EC and MoH local applications
  • Informed consent document development
  • Site start-up timeline alignment
  • Investigator and authority liaison

Nice-to-have

  • Mentoring SIA team members
  • Grant budget negotiation skills
  • Feasibility activity coordination
  • Strong English communication skills
  • Proactive issue resolution abilities

Key Requirements

  • Bachelor's degree or equivalent
  • 2+ years relevant experience
  • Knowledge of regional/national regulatory guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter