Regulatory and Site Start Up Specialist
Remote · South Korea
Job Summary
Regulatory Start-Up responsibilities including ensuring site activation readiness and regulatory compliance across assigned country/sites, preparing Clinical Trial Application forms and submission dossiers for CA/EC authorities, managing CA/EC interactions, updating regulatory submissions with project teams, maintaining project plans and regulatory trackers, developing country/site start-up plans, coordinating essential documents for site activation and IMP release, coordinating translations of documents, serving as SME for site activation data (e.g., CA/EC timelines, IRB/EC reviews, and budget requirements), supporting feasibility and investigator contracts, and ensuring audit readiness and TMF alignment. Requires a bachelor’s degree in life sciences or nursing (or equivalent), 1+ year in regulatory/start-up roles (CRO/pharma), strong communication and organizational skills, proficiency with standard information systems, and professional English proficiency.
Required Qualifications
- Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.
- A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
- 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
- Strong communication and organizational skills.
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
- Fluency in English.
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