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    Regulatory Affairs Officer - Melbourne, Australia - Healthcare Professionals Group

    Healthcare Professionals Group
    Healthcare Professionals Group Melbourne, Australia

    1 day ago

    Default job background
    Description
    Benefits
    • Must have unrestricted work rights for 12 months
    • Working within a global team
    • Monday to Friday only
    About the company
    Join a major global Biotechnology company known for its vibrant company culture and continuous growth.

    About the opportunity
    We are seeking a dedicated Regulatory Affairs Officer to provide essential technical and administrative support to the Global Regulatory Affairs division.

    Duties
    • Collaborate with the broader regulatory Affairs team in APAC area
    • Handle the preparation, compilation, and submission of Marketing Applications and variations for new or existing products
    • Assist in the preparation of various applications such as export listings and GMP licenses
    • Contribute to the preparation of regulatory documents for life cycle management including PSURs and annual reports
    • Ensure completeness of dossier preparations and monitor deadlines effectively
    • Assist in reviewing guidelines and preparing necessary comments
    • Support the preparation of Module 1 documentation and application submissions
    • Perform data entry and maintenance tasks in regulatory systems
    • Collaborate with product managers/scientists for SOP's/work instructions
    • Assist in monitoring metrics, reports, and training requirements
    Skills and Experience
    • Hold a Bachelor of Science degree or equivalent
    • Minimum one year of tertiary science education or proven experience in regulatory affairs
    • Relevant training in Regulatory Affairs
    • Ability to work in a diverse global regulatory environment
    • Strong team player and adept at building positive relationships
    • Sound understanding of regulatory affairs processes
    • Capable of initiating and implementing improvement initiatives

    Culture
    Despite its global presence, the company maintains a close-knit, family-like atmosphere and is committed to enhancing society's well-being.

    Why this opportunity is right for you
    This is a rewarding Full-time 12-month replacement contract based in Melbourne.

    How to Apply
    Click on the application button or reach out to Rohan Lallbeehary, Senior Recruitment Consultant for a private discussion.
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