Commercial Eyes has a great opportunity for a Regulatory Services Professional
Operating within the Regulatory Services Business Unit at Commercial Eyes, and reporting to the Regulatory Services Manager or Director, this role will involve the provision of both technical support and project management support to the Regulatory Services team, with the focus weighted to either a Senior Consultant or Project Leader role, depending on the successful candidate.
To be successful in this role you will:
- Have a strong understanding of the broader health technology sector, the regulatory and reimbursement environment, business and commercialisation strategies.
- 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 Services Professional, you will be responsible for…
- Providing strategic advice to clients regarding the Australian and New Zealand regulatory environments.
- Providing support to clients on the registration and listing of pharmaceuticals and medical devices 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.
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, such as competitive salary, a supportive & respectful culture and a pleasant 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.
Agencies please note: this recruitment assignment is being managed directly by the Commercial Eyes HR team. We will contact our preferred agency partners in the rare instance we require additional talent options. Your respect for this process is appreciated.
For more information about this role, please visit our Seek Ad.
Please contact Jeanette Lodge on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad.