Commercial Eyes is Australia’s leading Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & New Zealand. We provide a full suite of services through market insight and analysis, registration, reimbursement, patient support, medical information, and pharmacovigilance. With over 18 years of experience & a team of over 90 employees – what we do – and the consistent excellence with which we do it – sets us apart from other consultancies.
The Regulatory Services team at Commercial Eyes is expanding and looking to hire a new team member in the position of Associate Consultant. The Associate Consultant works within the Regulatory Services team to contribute to the Regulatory and Quality consulting practice.
In this role, you will be responsible for the preparation and submission of a range of regulatory applications for Australia and New Zealand. The Associate Consultant supports the delivery of a variety of projects, including the registration and listing of pharmaceuticals, biologicals, and medical devices.
This opportunity will work closely with the Regulatory Consultants, Senior Consultants, Project Leaders and/or Regulatory Services Manager to deliver a superior client experience and optimise project outcomes.
- Provide support to clients on the registration and listing of pharmaceuticals, biologicals and 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.
- Assist senior members of the team in the preparation of complex regulatory applications for submission to the TGA and other regulatory agencies.
- Assist with development of proposals.
- Develop a subject matter expert area(s).
- Review and QC applications, regulatory documentation as required.
- Liaise with other groups within Commercial Eyes as required.
- Mentor and/or train junior staff as required.
- Undergraduate qualifications in the pharmaceutical sciences or other scientific discipline.
- 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.
- 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.
- 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.
This role is based in Melbourne.
If you would like more information, call our People, Learning & Performance department on 03 9251 0777.