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Regulatory and Site Start Up Specialist

4 days, 11 hours ago
Australia
Full-time
Junior
Project Coordinator
Project and Program Management
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 148

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 to secure trial approvals.
  • Interact with Competent Authorities and Ethics Committees and handle their responses for study purposes.
  • Provide regular status updates on regulatory and ethics submissions to startup, regulatory, project management, and project team stakeholders.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Support development of study-specific startup plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs to align communication and secure site activation.
  • Review and manage collection of essential documents required for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country/site-specific requirements.
  • Coordinate document translations and support maintenance of audit and inspection readiness, including TMF filing.
  • Track site activation critical path data points such as CA, EC/IRB timelines, contracts, and budget negotiation requirements.
  • Support budget negotiation, investigator contracts, site outreach, and pre-study site visits when needed.

Requirements

  • Bachelor’s degree in life sciences or a related field, preferably in a scientific or healthcare discipline, or Registered Nurse (RN) equivalent.
  • 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, within a CRO, pharmaceutical, or 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 startup 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, RAC certification, or a Master’s in Regulatory Science is preferred.

Benefits

  • Opportunity to work on ground-breaking cancer therapy research.
  • Be part of a growing organization with exposure to precision medicine and rare disease/oncology programs.
  • Employee ideas and input are valued and encouraged.
  • Contribute to meaningful work that supports positive change within the company.
  • Equal opportunity employer practices and a non-discriminatory workplace.
  • Reasonable accommodation support for applicants with disabilities.
  • Access to an established privacy policy and applicant privacy notice for data protection.

Interested in this position?

Apply directly on the company website

Apply Now

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