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Regulatory and Site Start Up Specialist

1 day, 21 hours ago
Australia
Full-time
Junior
Compliance Manager
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 132

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 local regulatory requirements.
  • Interact with Competent Authorities and Ethics Committees and handle their responses.
  • Provide regular status updates on submissions and start-up progress to study leadership and project teams.
  • Maintain project plans, trackers, and regulatory intelligence tools for assigned responsibilities.
  • Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
  • Partner with site CRAs and other functions to align on communication and secure site activation.
  • Review and manage collection of essential documents needed for site activation and IMP release.
  • Customize patient information sheets and informed consent forms for country or site requirements.
  • Coordinate translations of study documents and maintain audit/inspection readiness and TMF filing compliance.

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 experience is highly beneficial.
  • 1+ year of experience as a Regulatory or Start Up specialist, or in a comparable role, in 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 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.

Interested in this position?

Apply directly on the company website

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