7h ago
Regulatory and Site Start Up Specialist
South Korea
full-timejunior Remotebiotech
๐ผ 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.
๐ฏ 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
๐ 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
โจ Nice to Have
- Relevant regulatory and site start-up experience
- Experience using milestone tracking tools
- Advanced degree (MD, PhD, PharmD) or RAC certification
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Phone Screenยท 30 min
- 2Interview with Hiring Managerยท 45 min
- 3Offerยท 1 week
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