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Regulatory and Site Start Up Specialist

24 minutes ago
South Korea
Full-time
Junior
Compliance Manager
Operations
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 106

Description

  • Deliver timely, high-quality site activation readiness for assigned countries and sites while identifying and mitigating risks.
  • Prepare Clinical Trial Application forms and submission dossiers, including initial submissions, amendments, and notifications, for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage communication with Competent Authorities and Ethics Committees, including handling study-related responses.
  • Provide regular updates on CA/EC submissions and startup status to study leadership, project managers, and project teams.
  • Maintain project plans, trackers, and regulatory intelligence tools related to assigned responsibilities.
  • Support development of study startup plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communication and secure site review and essential document collection for activation and IMP release.
  • Customize country- and site-specific Patient Information Sheets and Informed Consent Forms and coordinate document translations.
  • Coordinate with feasibility, clinical operations, project management, regulatory, and site contracts teams on startup deliverables and status.
  • Serve as a subject matter expert on site activation critical path data, including authority timelines, ethics submissions, contract and budget negotiation requirements, and other required reviews.
  • Support negotiation of study budgets and execution of investigator contracts when needed.
  • Maintain audit and inspection readiness and file documents in the TMF according to the TMF plan and study-specific requirements.

Requirements

  • Bachelor’s degree in life sciences or a related field, ideally in a scientific or healthcare discipline, or Registered Nurse (RN), or equivalent education, training, and experience.
  • Pharmacy qualification or pharmacist work experience is highly beneficial.
  • 1+ year of experience as a Regulatory or Start Up specialist, or in a comparable role, in a CRO or pharmaceutical/biotech environment, or equivalent relevant experience.
  • Strong communication and organizational skills.
  • Experience using computerized information systems, electronic spreadsheets, word processing, and email.
  • Fluency in English.
  • Relevant regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions, is preferred.
  • Experience using milestone tracking tools or systems is preferred.
  • Ability to prioritize workload and 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 work on groundbreaking cancer therapy research across a growing organization.
  • Employee input is valued and ideas are encouraged and nurtured.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for applicants with disabilities during the application process.
  • Privacy and applicant data protections are provided through the company’s privacy policy and CA privacy notice.

Interested in this position?

Apply directly on the company website

Apply Now

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