7h ago

Regulatory and Site Start Up Specialist

South Korea

full-timejunior Remotebiotech

๐Ÿ’ผ About This Role

You'll oversee site activation for clinical trials in South Korea, preparing and submitting regulatory documents to authorities and ethics committees. You'll ensure compliance with local regulations and ICH-GCP, managing timelines and communication across project teams to secure timely approvals.

๐ŸŽฏ What You'll Do

  • Prepare and submit clinical trial applications to authorities and ethics committees
  • Manage site activation timelines and mitigate risks
  • Partner with CRAs to collect essential documents for site activation
  • Maintain project trackers and regulatory intelligence tools

๐Ÿ“‹ Requirements

  • Bachelor's degree in life sciences or related field
  • 1+ years as Regulatory or Start Up specialist in CRO/pharma
  • Fluency in English
  • Experience with computerized information systems and spreadsheets

โœจ Nice to Have

  • Relevant regulatory and site start-up experience
  • Experience using milestone tracking tools
  • Advanced degree (MD, PhD, PharmD) or RAC certification

๐Ÿ“จ Hiring Process

Estimated timeline: 2-4 weeks ยท AI estimate

  1. 1Phone Screenยท 30 min
  2. 2Interview with Hiring Managerยท 45 min
  3. 3Offerยท 1 week
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