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.
