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 Senior Consultant works within the Regulatory, Quality & Compliance team to deliver a range of regulatory applications for Australia and New Zealand. The Senior 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.
- To primarily support regulatory activities requiring a sound knowledge of the type and quality of clinical and non-clinical evidence necessary to support new medicines registration, related life cycle management and maintenance activities.
- To provide support to clients on the registration and listing of pharmaceuticals, biologicals and medical devices in Australia.
- Review, critical evaluation, preparation and submission of regulatory dossiers to the TGA and Medsafe.
- Prepare literature based submissions, including the preparation of associated overviews and summaries.
- Assist clients in responding to regulatory agency questions.
- Assist clients with the maintenance of current registrations and listings.
- Prepare and submit safety related updates to Product Information documents at varying levels of complexity.
- Provide strategic advice to clients regarding the Australian and New Zealand regulatory environment.
- Attend meetings/teleconferences with clients and/or TGA or Medsafe 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.
- Liaise with other groups within Commercial Eyes as required.
- To provide project management support, as required, for all stages of client projects (including proposal writing, budget setting, budget and milestone management, and indirect staff management).
- Mentor junior staff as required.
- A minimum of 8 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.
- A degree in science, pharmacy or a related discipline.
- High level written and oral communication skills.
- Proven problem solving and project management skills.
- Reasonable computer literacy.
- Ability to deal with high level of confidentiality.
- Post-graduate qualifications in a relevant discipline.
- Previous consulting experience.
- Willingness to travel as required.
- Experience or aptitude for mentoring and leadership.
- Experience in technical/medical writing, particularly associated with medical device and pharmaceutical dossier requirements.
- Regulatory experience in jurisdictions outside of Australia and New Zealand.
- 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 or Sydney.
If you would like more information, call our People, Learning & Performance department on 03 9251 0777.