Consultant, Regulatory, Quality and Compliance

The Opportunity

We are looking for a dedicated Consultant to join our Regulatory, Quality & Compliance team to provide strategic advice to clients regarding regulatory environment and manage the registration and listing of medicines and medical devices in the Japan and Asia Pacific region.

In this full-time role, you will report to the Manager and play a pivotal role in supporting various projects, including new medicine applications, medical device inclusions, and life cycle management activities.

Some key responsibilities include:

Provide support and assistance to clients regarding type and quality of chemistry, manufacturing, and controls (CMC), clinical and non-clinical evidence to support new medicine registrations and medical device inclusions.
Support clients through the registration and listing process for pharmaceuticals, biologicals, and medical devices and assist with maintaining current registrations.
Review, critically evaluate, prepare, and submit regulatory dossiers to relevant agencies.
Manage clients and projects and support project teams as required.
Review and ensure quality and compliance of applications and documentation.
Assist in the preparation of literature-based submissions, including overviews and summaries.
Provide strategic regulatory advice to clients regarding the JAPAC regulatory environment.
Build and leverage strong networks across the life sciences sector to identify business opportunities for Commercial Eyes.

The Team

Our highly experienced Regulatory, Quality and Compliance team have in-depth knowledge of the complexity of the regulatory environment in the region. We assist our clients with the development of effective submission strategies and navigating through various challenges during the approval and life-cycle management process.

“One of the things I love the most about working at CEPL is the flexibility. I have members of my team working from around the world. As long as we have some working hours that overlap, everyone can work when and where they want” – Maria – Head of Regulatory, Quality & Compliance

Our head office is based in the heart of Melbourne’s CBD, where we operate from a collaborative workspace. We operate under a hybrid model and offer flexibility in accordance with our company’s flexible work policy.

About you

This is a unique opportunity for a skilled regulatory professional with extensive medical device experience and background in the pharmaceutical or healthcare industry. You are interested in consulting and keen to broaden your knowledge across different products and therapeutic areas, including medical devices, prescription, over the counter (OTC) and complementary medicines, sunscreens and cosmetics.

Desired qualifications and experience

Bachelor’s degree in science, pharmacy or other scientific discipline.
Post-graduate qualifications in a relevant discipline, is desirable.
Minimum 5 (five) years of experience in regulatory affairs, including experience in medical devices , preferably in a commercial setting.
Strong understanding of TGA and Medsafe regulations, guidelines, and working procedures.
Experience in preparing literature-based submissions, including associated overviews and summaries.
Client management and/or consulting experience would be highly regarded.