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Senior Regulatory Affairs Associate (Regulatory Affairs Generalist)

Parexel
Full time North Ryde, New South Wales Business Operations Specialists
Posted:
March 02, 2026
Location:
North Ryde, New South Wales, Australia

Job Description

When our values align, there's no limit to what we can achieve.
 

Key Accountabilities:

Project Execution

  • Previous experience working in industry in support of Global and/or local Regulatory teams, with comprehensive understanding of regional and global regulatory requirements, guidelines and processes and in-depth expertise on local health authority management
    • Strong knowledge of post-authorization lifecycle maintenance procedures e.g. variations, renewals, PSURs, etc, timelines and requirements, to support maintenance of multiple licenses, including management of HA interactions and responses to questions 
    • Use of document management tools (internal systems) and external platforms
    • Prepare, organize and coordinate local specific documentation e.g. module 1 to meet national submission requirements and be responsible for keeping up-to-date local national systems as per local legislation ( renewals, PSURs, label updates...

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    Job Overview

    Job Type: Full time
    Location: North Ryde, Australia
    Posted: March 02, 2026
    Deadline: April 11, 2026