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    Executive Level 1 - Canberra, Australia - Australian Department of Health and Aged Care

    Australian Department of Health and Aged Care
    Australian Department of Health and Aged Care Canberra, Australia

    5 days ago

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    Description

    Executive Level 1 - International Work-Sharing Coordinator

    The Therapeutic Goods Administration, within the Department of Health and Aged Care, is looking for an enthusiastic and high-performing team member to join the Application and Advisory Management Section.

    Reporting to the Director, the International Work-Sharing Coordinator will work as part of a team to manage the prescription registration process for international work-sharing and collaboration submissions, and is a point of liaison between sponsors, internal specialist and technical staff and overseas regulators.

    Position Duties:


    • Providing technical knowledge to coordinating the pre-market evaluation process for new medicines and variations to existing medicines.


    • Planning and monitoring evaluations, including negotiating milestones, providing progress reports to ensure agreed timeframes are met.


    • Maintaining complete, auditable documentary evidence relating to prescription medicine submissions.


    • Drafting and preparing correspondence to industry stakeholders based on the outcomes of evaluations and contribute to the development of other documents and communications materials as required.


    • Liaising, engaging, and collaborating with internal and external stakeholders to resolve complex issues encountered during the prescription medicines registration process.


    • Developing and managing international collaboration associated with work-sharing initiatives across the Access Consortium, Project Orbis and COVID-19.


    • Developing and maintaining structures and processes that support appropriate applications being work-shared.


    • Using innovative solutions to actively source and negotiate new work-sharing initiatives.


    • Assisting in the proactive communication and management of current New Chemical Entity (NCE) work-sharing pilots.


    • Directly liaising with international regulators, internal TGA stakeholders, and industry to coordinate information-sharing opportunities and progress work-sharing initiatives, ensuring transparency and consistency in our approach.


    • Analysing information on comparable overseas regulators' registration pathways and electronic lodgement of applications associated with the prescription medicines registration process.


    • Assessment of evaluation reports (non-clinical/clinical/quality) produced internally and internationally and reporting on the outcomes, including the materials that were evaluated.


    • Reviewing national and international regulatory pathways to ensure they are contemporary and flexible to accommodate any future digital transformation initiatives


    • Contributing to strategic direction and operational planning activities for prescription medicines evaluation processes, and the section broader goals; and


    • Maintaining flexibility in contributing to team goals and broader organisational objectives by undertaking other tasks as required and directed.

    Mandatory Qualification:

    To be eligible for this position applicants must hold a degree in a relevant scientific field such as pharmacy, chemistry, biochemistry, toxicology or biological sciences, from an Australian tertiary institution or comparable overseas qualification.

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