Regulatory And Site Start Up Specialist

TL;DR

Regulatory and Site Start Up Specialist: Managing the regulatory submission process and site activation readiness for clinical trials with an accent on compliance with local laws and ICH-GCP principles. Focus on coordinating between Competent Authorities, Ethics Committees, and internal project teams to ensure timely site activation and study document management.

Location: Must be based in South Korea (Remote)

Company

A global Clinical Research Organization specializing in precision medicine, oncology, and rare disease research.

What you will do

• Prepare and submit Clinical Trial Application dossiers to Competent Authorities and Ethics Committees.
• Manage site activation readiness and mitigate risks to ensure project timelines are met.
• Customize country-specific Patient Information Sheets and Informed Consent Forms.
• Coordinate document translations and maintain essential project trackers.
• Partner with CRAs and internal teams to ensure alignment on site activation and IMP release requirements.
• Maintain audit readiness and ensure all documentation is filed according to TMF plans.

Requirements

• Must be based in South Korea.
• Bachelor’s degree in life sciences, healthcare, or equivalent (Registered Nurse or Pharmacist preferred).
• Minimum 1 year of experience as a Regulatory or Start Up specialist in a CRO or pharmaceutical/biotech industry.
• Fluency in English required.
• Strong organizational skills and proficiency with electronic information systems.
• Knowledge of local clinical trial laws and international ICH-GCP principles.

Nice to have

• Advanced degree in medical or life sciences (MD, PhD, PharmD).
• RAC certification or Masters in Regulatory Science.
• Experience with milestone tracking tools and contract negotiations.

Culture & Benefits

• Opportunity to work on groundbreaking cancer therapies.
• Collaborative environment where employee contributions are valued.
• Commitment to professional growth and development within a global organization.
• Equal Opportunity Employer with inclusive hiring practices.