Job Title

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. - 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. Required education: Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline. Required experience: Minimum of 3 years of experience in regulatory affairs Preference for experience in Australian and New Zealand in a commercial environment. Required language: English Required technical skills: - 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. - Interest in the practice of consulting. - An appetite for learning and development.