About the Role
Job Description:
General Description:The Regulatory Affairs Associate is responsible for ensuring the regulatory compliance of therapeutic products in Australia and New Zealand, through clinical trial applications and notifications, supply reports, GMP applications and import/export permit applications.
Essential Functions of the job:
Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
Prepare, submit and support clinical trial applications and variations in Australia and New Zealand.
Submit GMP renewal and variation applications for Australia.
Collate and submit supply reports for Australia.
Arrange for import/export permits for products to move in and out of Australia.
Develop and maintain standard operating procedures or local working practices.
Maintain current knowledge of releva...
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