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.

Minimum of 3 years of experience in regulatory affairs Preference for experience in Australian and New Zealand in a commercial environment.

English

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.