Regulatory Professional

The company…

At Commercial Eyes, we are currently offering successful candidates the opportunity to thrive in a leading life sciences commercialisation consultancy, with a reputation for consistent excellence in delivering high-quality customer-focussed results for local and international clients operating in the Australian & New Zealand pharma, medical device and biotech industries.

Our consultants draw on experience from the unique exposure that comes with being part of a large consultancy offering a full suite of commercialisation services from market insights, through the complex processes of registration and reimbursement, to marketed product requirements such as patient support and pharmacovigilance. What we do – and the consistent excellence with which we do it – sets us apart from other consultancies.

Fundamental to our growth and success has been recruiting pragmatic, experienced and knowledgeable industry professionals.

The Regulatory Quality & Compliance team…

The Regulatory Quality & Compliance (RQC) team is a highly experienced group of consultants with an in-depth knowledge of the regulatory processes and requirements in the Australian and New Zealand markets. The team consists of consultants with extensive backgrounds in prescription, OTC and complementary medicines, medical devices, food products and cosmetics.

Consultants within the RQC team understand the regulatory approval and compliance challenges that sponsors face and the particular environment in which products will be launched. Given the breadth of consultative services offered by Commercial Eyes, RQC consultants are able to work closely with consultants in Market Insight, Market Access, Medical Communication, Patient Engagement and Medical Services, where required.

The volume of work being undertaking at present is rapidly increasing and as a result we are looking for additional experienced regulatory professionals to join the team.

The role…

Operating within the RQC Business Unit within our Commercialisation division and reporting to the Regulatory Quality & Compliance Manager or Head of Regulatory Quality & Compliance, this role will involve the provision of both technical support and project management support to the team.

To be successful in this role you will:

• Have a strong understanding of the regulatory environment in Australia and New Zealand.
• Take responsibility for individual tasks and projects, and work closely with client teams.
• Have rigorous analytical skills, integrity, and the ability to handle the challenges inherent to the commercialisation process.
• Be excited about delivering substantial and lasting change to our clients' businesses, and enjoy brainstorming potential issues and their solutions.
• Be relaxed and confident when communicating with clients.
• And, importantly, be comfortable with ambiguity – seeing it as an opportunity to generate insights.

As a Regulatory Professional, you will be responsible for…

• Providing advice to clients regarding the Australian and New Zealand regulatory environments.
• Providing support to clients on the registration and listing of pharmaceuticals and biotechnology products in Australia and New Zealand.
• Reviewing, critically evaluating, preparing and/or submitting regulatory dossiers to the TGA and Medsafe.
• Assisting senior team members in the preparation of literature based submissions, including the preparation of associated overviews and summaries.
• Assisting clients in responding to agency questions.
• Assisting clients with the maintenance of current registrations and listings.
• Attending meetings/teleconferences with clients and/or TGA or Medsafe, as required.
• Building strong interpersonal networks across the life sciences sector and drawing on these to identify potential short and long-term business opportunities for Commercial Eyes.
• Liaising with other groups within Commercial Eyes as required.
• Mentoring junior staff as required.

About you….

Ideally you will possess the following qualifications and experience to be considered for this role:

• Qualifications (preferably post graduate) in a science, pharmacy, engineering or related discipline.
• Relevant professional industry experience (min. of 4 years) in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
• Working knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures.
• Highly developed communication, organisational and problem-solving skills.
• Proven ability to manage projects.
• Ability to work within a highly confidential environment.
• Ability to work independently.
• Attention to detail and ability to produce work of a consistently high quality.
• Ability to progress multiple work streams and concepts simultaneously.
• Leadership and teamwork orientated.
• Proficient computer literacy in Microsoft Office, Adobe Acrobat and Outlook.
• Australian permanent resident or citizen.

Preference would also be given to candidates with the following attributes:

• Previous consulting experience.
• Experience with both medicines and medical devices.
• Prior experience with due diligence undertakings.

Become part of our vision and in return…

We provide employees at all levels with challenging work from diverse clients within the life sciences sector, and each individual has the opportunity to continually learn and grow.

The opportunity is a rewarding one that offers all the traditional benefits of employment, a supportive & respectful culture and a fun work environment, as well as a strong sense of teamwork, job satisfaction and achievement.

By joining Commercial Eyes, you will be able to expand your professional network within the industry whilst working in a well-known professional services organisation that recognises talent and expertise.

Please note:

• Commercial Eyes does not accept applications from recruitment agencies.
• To be considered for this role, you must be a permanent resident or citizen of Australia with full work rights.

Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.