Regulatory and Site Start Up Specialist
Remote · South Korea
Job Summary
Regulatory and Start-Up Specialist responsible for timely and high-quality site activation readiness within assigned country/sites, preparation and submission of Clinical Trial Applications and regulatory dossiers to authorities and ethics committees, regular updates to regulatory leads and project teams, maintenance of project plans and regulatory intelligence tools, development of start-up plans, collaboration with site CRAs, collection and coordination of essential site activation documents, translation coordination, and serving as SME for site activation data points including CA/EC timelines and investigator contracts. The ideal candidate will have a life sciences bachelor’s degree or RN, 1+ year regulatory/start-up experience (CRO/pharma/biotech), strong communication/organizational skills, English fluency, and familiarity with regulatory submissions and site start-up activities; advanced degrees or RAC/Regulatory Science background are considered a plus.
Required Qualifications
- Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline) or Registered Nurse (RN) or equivalent
- 1 year or more as a Regulatory or Site Start-Up (SU) specialist (or comparable role) in CRO/pharmaceutical/biotech industry or equivalent
- Strong communication and organizational skills
- Experience using computerized information systems, electronic spreadsheets, word processing and email
- Fluency in English
- Preferred: experience in feasibility, contract negotiations, CA/EC/IRB submissions and regulatory site start-up processes
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