Regulatory Affairs Specialist

1 week ago


Melbourne, Victoria, Australia Hengandhurst Full time
Key Responsibilities

The Senior Regulatory Affairs Associate will ensure successful regulatory submissions and approvals across Australia, New Zealand, and the Southeast Asia (SEA) region.

The role involves preparing and managing regulatory dossiers for submission to local authorities. This includes leading interactions with regulatory agencies, licensing partners, and external consultants to facilitate approvals.

Ongoing compliance is ensured by managing variations and renewals, while collaborating cross-functionally with Medical, Quality, and Commercial teams to support product launch activities.

  • Prepare and manage regulatory dossiers for submission to TGA, Medsafe, and other regional authorities.
  • Lead interactions with regulatory agencies, licensing partners, and external consultants to facilitate approvals.
  • Manage ongoing compliance by overseeing variations and renewals.


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