Senior Consultant, Regulatory, Quality & Compliance (Consulting)

The Opportunity

We are excited to welcome an enthusiastic Senior Consultant to our team on a full-time basis. In this dynamic role, you will be a key player within our Regulatory, Quality & Compliance team, delivering a wide range of regulatory applications across the Japan and Asia Pacific region.

As a Senior Consultant, you will manage client projects, collaborating closely with team members to ensure an exceptional client experience, optimise project outcomes, and enhance our team’s culture and capabilities. This position reports to the Senior Manager, Regulatory, Quality, and Compliance. If you are eager to make a significant impact and thrive in a dynamic environment, this is a position for you!

Key responsibilities include:

Act as a subject matter expert and provide support and assistance to clients regarding type and quality of clinical and non-clinical, chemistry, manufacturing, and controls (CMC) 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 documentation. Ensure quality control of applications, regulatory, quality, and compliance documents.
Assist clients in responding to regulatory agency questions and with maintaining current registrations, listings, and inclusions.
Develop strong relationships with existing clients, providing high-quality consulting services to enhance client satisfaction and loyalty.
Build strong networks within the life sciences sector to identify potential business opportunities and act as a brand ambassador.
Proactively identify business development opportunities and work with existing and potential clients to understand their needs.
Act as Project Manager, providing leadership through client liaison, project scoping and proposal development, team resourcing, project management, delivery, and client follow-up.

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.

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.

When you become part of our team, you’ll immediately feel welcomed, supported, and appreciated. Our unique and challenging consulting environment fosters a strong sense of collaboration, and it is second to none, even when working remotely. At Commercial Eyes we:

Thrive on providing creative solutions to complex problems.
Love being exposed to diverse projects.
Feel comfortable with ambiguity and see it as an opportunity to generate insights.
Enjoy hands-on work as well as being the subject matter expert.
Feel inspired to deliver work that makes a difference to people’s lives through health.
Work flexibly and adapt quickly to changing priorities.

About you

This is a great opportunity for a skilled regulatory professional with an extensive background in the pharmaceutical or life-science space. If you are passionate about consulting and eager to broaden your expertise across a diverse range of products and therapeutic areas—including prescription and-over-the counter (OTC) medicines, complementary medicines, sunscreens, medical devices, and cosmetics—this role is an ideal fit for you.

You are a dynamic individual with a proactive and independent approach to problem-solving. You should possess high-level written and oral communication skills, enabling you to articulate complex regulatory concepts clearly and effectively. Your proven problem-solving abilities and strong project management skills will be crucial in navigating regulatory challenges and delivering successful project outcomes.

In addition to your technical expertise, we value leadership and mentorship skills. Experience or a strong aptitude for guiding and developing team members would be welcomed as they would play a key role in fostering a collaborative and high-performing team environment.

Desired qualifications and experience

Bachelor’s degree in science, pharmacy or other scientific discipline.
Post-graduate qualifications in a relevant discipline, is desirable.
Minimum 8 (eight) years of experience in regulatory affairs, preferably in a commercial setting.
Strong understanding of TGA and Medsafe regulations, guidelines, and working procedures.
Experience in technical/medical writing, particularly associated with therapeutic product requirements.
Experience in the review, critical evaluation and presentation of clinical and non-clinical data.
Regulatory experience in jurisdictions outside of Australia and New Zealand, is desirable.
Client management and/or consulting experience would be highly regarded.