Regulatory Affairs Executive (Australia Market)

Role & responsibilities (Australia Market)

• Support preparation and submission of regulatory applications, variations, amendments, and other applicable submissions to TGA.
• Compile and review regulatory documentation to ensure submission content is complete, accurate, and consistent.
• Provide regulatory support to cross-functional teams.
• Handle TGA queries and deficiency responses for regulatory submissions.
• Communicate with partners for timely availability of required information and documents.
• Ensure timely submission of variations and other regulatory requests to the relevant regulatory authority.
• Maintain regulatory project trackers.
• Support post-approval regulatory maintenance and lifecycle activities.

Preferred candidate profile

• 2 to 7 Years of Experience required for the Australia Market.