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Regulatory and Site Start Up Specialist

8 hours, 28 minutes ago
South Korea
Full-time
Junior
Compliance Manager
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 140

Description

  • Deliver site activation readiness on time and with high quality across assigned countries and sites, while identifying and mitigating risks.
  • Prepare Clinical Trial Application forms and submission dossiers for initial filings and amendments/notifications to Competent Authorities, Ethics Committees, and other local bodies.
  • Manage interactions with Competent Authorities and Ethics Committees, including handling their questions and responses.
  • Provide regular updates on submission status and deliverables to the Start Up Lead, Regulatory Lead, Project Manager, and project team.
  • Maintain project plans, trackers, and regulatory intelligence tools related to assigned responsibilities.
  • Support development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs and other functions to align communication and secure site activation.
  • Review and manage essential documents required for site activation and IMP release.
  • Customize country- and site-specific Patient Information Sheets and Informed Consent Forms, and coordinate document translations.
  • Act as a subject matter expert on local clinical trial laws, timelines, and critical path data points to support timely site activation and audit readiness.

Requirements

  • Bachelor’s degree in life sciences or a related scientific or healthcare field, or Registered Nurse (RN), or an equivalent combination of education, training, and experience.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • At least 1 year of experience as a Regulatory or Start Up Specialist, or in a comparable role, in a CRO or pharmaceutical/biotech environment.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Relevant experience in regulatory and site start-up activities, including feasibility, contract negotiations, and CA/EC/IRB submissions, is preferred.
  • Experience using milestone tracking tools or systems is preferred.
  • Ability to prioritize workload to meet deadlines is preferred.
  • Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or a Master’s in Regulatory Science is preferred.

Benefits

  • Opportunity to contribute to a growing organization focused on groundbreaking cancer therapies.
  • Your ideas and input are valued and can influence positive change within the company.
  • Employees are recognized and appreciated for their contributions.
  • Equal Opportunity Employer policies promote fair employment decisions.
  • Reasonable accommodations are available for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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