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Regulatory and Site Start Up Specialist

1 hour, 55 minutes ago
South Korea
Full-time
Junior
Project Coordinator
Project and Program Management
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 105

Description

  • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies.
  • Manage initial submissions, amendments, and notifications within required timelines and in line with local requirements, company SOPs, and ICH-GCP.
  • Interact with Competent Authorities and Ethics Committees and handle their responses.
  • Provide regular status updates on CA/EC submissions to the Start Up Lead, Regulatory Lead, and Project Team.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Support development of study start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communications and secure site activation.
  • Review and manage collection of essential documents for site activation and IMP release.
  • Customize country- or site-specific Patient Information Sheets and Informed Consent Forms.
  • Coordinate translations for study documents.
  • Maintain communication with feasibility, clinical operations, project management, regulatory, and site contracts teams on status and deliverables.
  • Act as subject matter expert for site activation critical path data points, including ethics timelines, contracts, budgets, and other required reviews.
  • Support negotiation of study budgets and execution of investigator contracts when required.
  • Support feasibility efforts in site outreach and investigator interest assessment when required.
  • Maintain audit and inspection readiness and file documents in the TMF according to the study plan.
  • Support pre-study site visits when needed.

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 experience as a pharmacist is highly beneficial.
  • At least 1 year of experience as a Regulatory or Start Up Specialist, or in a comparable role, within a CRO, pharmaceutical, or biotech company.
  • 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 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 therapies and other clinical research programs.
  • Employees’ ideas are valued and nurtured, with opportunities to help drive positive change.
  • Equal Opportunity Employer status with nondiscrimination across protected characteristics.
  • Reasonable accommodation support for applicants with disabilities.
  • Privacy policy and CA privacy notice for applicant data handling.

Interested in this position?

Apply directly on the company website

Apply Now

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