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Alimentiv

Posted 27 days ago

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Regulatory Affairs Specialist (Australia)

SydneyRemote

AI Summary

A Regulatory Affairs Specialist manages clinical trial application submissions and regulatory filings, coordinates regulatory risk assessments and audits, and provides regulatory, ethics and pharmacovigilance guidance to sponsors and project teams.

About this role

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews.

Unit Management

  • Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites.
  • Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner.

    • Client Services

  • As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.
  • Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client.

    • Regulatory Strategy Development

  • Identify changes in clinical research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, quality assurance) when appropriate, to meet or exceed compliance requirements of evolving regulatory initiatives.
  • Participate in specialized conferences/meetings to increase knowledge as needed.

    • Project Support

  • Regularly respond to registration requests and work with project teams to identify regulatory requirements.
  • Assist in the preparation of regulatory submissions and support summaries.
  • Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.

    • Qualifications

  • Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
  • The successful candidate will possess strong knowledge of LATAM clinical trial regulations.
  • Fluency in English and Spanish (written and verbal) required.

    • Working Conditions

  • Home-based
  • *Accommodations for job applicants with disabilities are available upon request.

    • Skills

    Clinical Trial RegulationsCompetent AuthoritiesEthics CommitteesLATAM Clinical Trial RegulationsQuality AssuranceRegulatory AgenciesRegulatory Risk AssessmentsRegulatory SubmissionsSPSS

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