Position Overview
Specific activities and responsibilities:
Provide support to clients on the registration and listing of pharmaceuticals, biologicals and medical devices in Australia and New Zealand and (JAPAC) region.Provide support to clients with the maintenance of current registrations and listings.Review, critically evaluate, prepare and submit regulatory dossiers to the TGA and Medsafe.Act as Project Lead/Manager, participate in assigned projects and support project teams as requested.Assist clients in responding to TGA and Medsafe questions.Develop a subject matter expert area(s).Assist in the preparation of literature-based submissions, including the preparation of associated overviews and summaries.Provide strategic advice to clients regarding the JAPAC regulatory environment.Preparation, review and update of quality documentation.Assist with development...