This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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
Provide eCTD publishing support
Review, critically evaluate, prepare and submit regulatory dossiers to the TGA and Medsafe
Assist clients in responding to TGA and Medsafe questions
Assist senior members of the team in the preparation of complex regulatory applications for submission to the TGA and other regulatory agencies
Assist with project and client management as required
Management and preparation of GMP clearance applications for submission to the TGA and/or other regulatory agencies, as required
Preparation, review and update of quality documentation
Requirements:
Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline
Minimum of 3 years of experience in regulatory affairs
Preference for experience in Australian and New Zealand in a commercial environment
English language
Good knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures
Reasonable computer literacy
Proven experience dealing with a high level of confidentiality
Good problem solving and project management skills
Ability to work to deadlines
Attention to detail
Excellent written and spoken communication and interpersonal skills