The Associate Consultant works within the Regulatory, Quality & Compliance team to contribute to the regulatory, quality and compliance consulting practice. The Associate Consultant is responsible for the preparation and submission of a range of regulatory applications, compliance documents and related activities for Australia and New Zealand. The Associate Consultant supports the delivery of a variety of projects, working closely with the Regulatory, Quality & Compliance Administrators, Associates, Associate Consultants, Consultants, Senior Consultants, Project Leaders, Manager and/or Associate Director to deliver a superior client experience and optimise project outcomes.
- Provide support to clients on the registration and listing of medicines or medical devices in Australia and New Zealand.
- 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.
- Assist clients in responding to TGA and Medsafe questions.
- Develop a subject matter expert area(s).
- Review and QC applications, regulatory, quality and compliance documentation as required.
- Mentor and/or train junior staff as required.
- Liaise with other groups within Commercial Eyes as required.
- Other reasonable duties as requested.
- A minimum of 3 years of experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
- Good knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures.
- Reasonable computer literacy.
- 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.
- Work for a company consistently delivering excellence.
- Deliver work that makes a difference to people’s lives through health.
- Be a member of a team who supports and cares for each other.
- Be part of an inclusive and diverse working environment.
- Commercial Eyes does not accept applications from recruitment agencies.
- To apply for this role you must be a permanent resident or citizen of Australia.
Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.
If you would like more information, email our People, Learning & Performance department at [email protected]