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Regulatory Affairs Specialist (Australia)

1 month, 2 weeks ago
Australia
Full-time
Mid Level
Compliance Manager
Legal
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 32

Description

  • Coordinate the day-to-day delivery of regulatory services and processes for projects, vendors, and clinical sites.
  • Compile regulatory filings, submissions, and revisions for clinical trial applications.
  • Conduct or assist with regulatory and safety reviews.
  • Create regulatory tools, educational materials, and training resources for project teams.
  • Provide regulatory, ethics, and pharmacovigilance guidance to stakeholders as the subject matter specialist.
  • Represent the unit in project meetings, audits, and interactions with regulatory, ethics, and government authorities.
  • Respond to regulatory queries on behalf of clients when appropriate.
  • Identify changes in clinical research regulations and industry best practices and help implement updated corporate regulatory strategies.
  • Support preparation of regulatory submissions, summaries, and registration requests.
  • Maintain, archive, and ensure proper control of project and clinical site files and documents.

Requirements

  • Undergraduate degree required.
  • 4-6 years of relevant experience in Clinical Research or Regulatory Affairs.
  • Strong knowledge of LATAM clinical trial regulations.
  • Fluency in English and Spanish, both written and verbal, required.
  • Experience supporting regulatory submissions and clinical trial applications.
  • Ability to stay current on clinical research regulatory requirements and industry best practices.
  • Experience working with project teams, sponsors, researchers, or regulatory authorities is preferred.
  • Ability to coach peers or provide input for staff performance reviews may be required.

Benefits

  • Home-based work arrangement.
  • Accommodations for job applicants with disabilities available upon request.

Interested in this position?

Apply directly on the company website

Apply Now

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