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Regulatory and Site Start Up Specialist

1 month ago
South Korea
Junior
Operations Specialist
Operations
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 31

Description

  • Coordinate timely, high-quality site activation readiness and identify or mitigate activation risks.
  • Prepare clinical trial applications and submission dossiers for Competent Authorities, IRBs, Ethics Committees, and other local bodies.
  • Interact with regulatory and ethics authorities and manage responses to their questions.
  • Maintain project plans, trackers, regulatory intelligence tools, and site activation critical-path data.
  • Prepare, review, translate, and manage essential documents required for site activation and IMP release.
  • Customize country- and site-specific Patient Information Sheets and Informed Consent Forms.
  • Collaborate with CRAs, Clinical Operations, Project Management, Feasibility, Regulatory, and Site Contracts teams.
  • Support site budget negotiations, investigator contract execution, feasibility outreach, and pre-study site visits as needed.
  • Maintain audit and inspection readiness and file documents according to TMF and study-specific plans.
  • Support process improvements, training, mentoring, and development of 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 as a Regulatory or Site Start-Up Specialist, or in a comparable CRO, pharmaceutical, or biotechnology role.
  • Strong communication, organizational, prioritization, and deadline-management skills.
  • Experience with computerized information systems, spreadsheets, word processing, and email.
  • Fluency in English and, where applicable, the local language of the country of employment.
  • Relevant country-specific experience with regulatory and site start-up activities, including feasibility, contract negotiations, and CA/EC/IRB submissions (preferred).
  • Experience using milestone tracking tools or systems (preferred).
  • Advanced medical or life sciences degree, RAC certification, or Master’s in Regulatory Science (preferred).
  • Knowledge of applicable local and international clinical trial regulations, guidelines, and ICH-GCP principles.

Interested in this position?

Apply directly on the company website

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