The Consultant works within the Regulatory, Quality & Compliance team to deliver a range of regulatory applications for Australia and New Zealand. The Consultant manages client projects, working closely with other members of the team, to deliver a superior client experience, optimise project outcomes, and contribute to the culture and capabilities of the team.
- Manage the registration and listing of medicines or medical devices in Australia and New Zealand.
- Provide support on regulatory activities requiring a sound knowledge of the type and quality of evidence necessary for new medicines registrations or medical device inclusions, as well as related life cycle management activities.
- Provide strategic advice to clients regarding the Australian and New Zealand regulatory environment.
- Review, critical evaluate, prepare and submit regulatory dossiers to the TGA and Medsafe.
- Assist in the preparation of literature-based submissions, including the preparation of associated overviews and summaries.
- Assist senior members of the team in the preparation of complex regulatory applications for submission to the TGA and other regulatory agencies.
- Assist clients with the maintenance of current registrations and listings.
- Assist clients in responding to regulatory agency questions.
- Attend meetings/teleconferences with clients and/or TGA or Medsafe as required.
- Undertake project and client management as required.
- Mentor junior staff as required.
- Build strong interpersonal networks across the life sciences sector and draw on these to identify potential short and long-term business opportunities for Commercial Eyes.
- Assist with development of proposals.
- Liaise with other groups within Commercial Eyes as required.
- Undergraduate qualifications in pharmaceutical sciences or other scientific discipline.
- A minimum of 5 years’ experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
- Experience in the review, critical evaluation and presentation of clinical data.
- Good knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures.
- Reasonable computer literacy.
- Proven experience dealing with a high level of confidentiality.
- Proven problem solving and project management skills.
- Attention to detail.
- Interest in the practice of consulting.
- High level written and oral communication skills.
- Post-graduate qualifications in a relevant discipline.
- Previous consulting experience.
- Willingness to travel as required.
- 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]