12 дней назад
Regulatory and Site Start Up Specialist
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory and Site Start Up Specialist (Clinical Trials): Managing regulatory submissions, essential documents, informed consent forms, and site activation readiness for clinical trials in South Korea with an accent on competent authority and ethics committee interactions, local compliance, and cross-functional coordination. Focus on preparing submission dossiers, tracking activation milestones, supporting site contracts and budgets, and maintaining inspection-ready trial documentation.
Location: Remote, South Korea
Company
is a contract research organization integrating clinical trial execution with scientific, laboratory, and data science expertise, with a focus on oncology and rare disease.
What you will do
- Manage clinical trial submissions and amendments to competent authorities, IRBs, ethics committees, and other local bodies.
- Prepare submission dossiers, clinical trial application forms, informed consent forms, patient information sheets, translations, and essential documents.
- Drive site activation readiness by tracking regulatory, contract, budget, and document milestones and mitigating risks.
- Coordinate with regulatory, clinical operations, feasibility, project management, site contracts, and assigned site CRAs.
- Interact with authorities and ethics committees, manage responses, and provide regular submission status updates.
- Maintain regulatory intelligence, audit and inspection readiness, TMF documentation, and country-specific tools and guidance.
Requirements
- Bachelor’s degree in life sciences or a related field, registered nurse qualification, or equivalent education, training, and experience.
- At least 1 year of experience in regulatory affairs or site start-up in a CRO, pharmaceutical, or biotechnology environment, or comparable relevant experience.
- Fluent English and Korean or the local language of South Korea are required.
- Strong communication and organizational skills with the ability to prioritize work and meet deadlines.
- Experience with computerized information systems, spreadsheets, word processing, and email.
Nice to have
- Experience with regulatory and site start-up activities in South Korea, including feasibility, contract negotiations, and authority or ethics committee submissions.
- Experience using milestone tracking tools and systems.
- Advanced degree in medical or life sciences, RAC certification, or a master’s degree in regulatory science.
Culture & Benefits
- Remote work based in South Korea.
- Opportunity to support clinical trials in oncology and rare disease.
- Collaboration across regulatory, clinical operations, feasibility, project management, and site contracts functions.
- Opportunities to contribute to process improvement, training, and mentoring.
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