Consultant - Regulatory, Quality & Compliance

Commercial Eyes Pty Ltd
Melbourne
CBD & Inner Suburbs
Healthcare & Medical
Pharmaceuticals & Medical Devices
Full time
Posted 17d ago

About us:

Commercial Eyes is the foremost life sciences commercialisation business in Australia and New Zealand. With a team of over 100 people and 20 years of expertise, we have assisted more than 650 pharmaceutical, medical device, diagnostic and consumer healthcare companies. 

No other life sciences commercialisation consultancy offers the full suite of services we do; market insight and analysis including competitive intelligence, registration, pricing and reimbursement/health economics, patient support, medical information, pharmacovigilance and medical communications. 

We have a variety of flexible working arrangements in place to accommodate our people’s needs. Our head office is located at 500 Collins Street and with one of our values being about “flexibility”, our people can choose to work either remotely or in the head office.

 

“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 Dionyssopoulos - Head of Regulatory, Quality & Compliance 

 

The Opportunity

We are looking for a Consultant to join our Regulatory, Quality & Compliance team to deliver a superior client experience and optimise project outcomes. This is a full-time position to support the delivery of a variety of projects, including the registration and listing of pharmaceuticals, biologicals and medical devices.

As a Consultant, you are responsible for project and client management, whilst contributing to the culture and capabilities of the team. This role supports clients with the implementation of effective submission strategies that help them meet their regulatory requirements and enhance their regulatory, quality and compliance activities.

 

About You

This is a unique opportunity for someone with regulatory or quality assurance 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: prescription, over the counter (OTC) and complementary medicines, sunscreens, medical devices and cosmetics.

The breadth of consultative services offered by Commercial Eyes means our Regulatory, Quality & Compliance team have the opportunity to work with different clients across different projects. We manage over 150 projects and on average, 30 major submissions to regulatory authorities annually.

 

Working as a Consultant at CEPL

Reflecting our clients’ complex and challenging needs, our amazing and diverse team of consultants come from a wide range of professional backgrounds, including life sciences, pharmacy, medicine, and other scientific disciplines. 

You will love working as a Consultant at CEPL if you:

  • 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.
  • Enjoys 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.

 

“I love consulting because of the depth and breadth of clients and projects I get to work with and having the opportunity to be at the forefront of innovation and technology within the industry”– Jo Adkins, Head of Market Insight

 

Key skills and experience 

  • Undergraduate qualifications in pharmaceutical sciences or other scientific discipline.
  • Experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
  • Quality Assurance experience or GMP clearance experience.
  • Sound knowledge of the type and quality of evidence necessary for new medicines registrations or medical device inclusions, as well as related life cycle management activities.
  • Experience in the review, critical evaluation and presentation of clinical data.
  • Good knowledge of TGA and Medsafe legislation, regulations, guidelines and working procedures.

 

Your Impact

  • Provide strategic advice to clients regarding successful product registration and compliant lifecycle management in the Australian and New Zealand regulatory environment.
  • Manage and maintain registration and listing of medicines and/or medical devices for the client projects. This includes reviewing, critical evaluation, preparation and submission of regulatory dossiers to the TGA and Medsafe.
  • Assist the client in liaising with regulatory agencies (i.e. TGA and Medsafe), responding to regulatory agency questions, etc.
  • Assist in the preparation of literature-based submissions, including the preparation of associated overviews and summaries.
  • Assist senior members of the team and mentor junior colleagues throughout the preparation of complex regulatory applications for submission to the TGA and other regulatory agencies.
  • Work closely with the market insight, market access and medical services teams to provide broad cross-functional support where 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. 

 

The Rewards… 

  • A “family feel” culture in a growing and sustainable business  
    • At CEPL you are not just a number, you become a member of a team who supports and cares for each other. Everyone gets to know each other by name regardless of where you work from.
    • Our team is multicultural and diverse, so you'll get to work with a variety of people from different ethnicities, backgrounds and with a broad range of experiences.
    • We are committed to supporting the community in which we work. The projects we support are both sustainable and recurrent including: Yalari, The Smith Family, The Purple House, Australian Red Cross and more.
  • Health and Wellbeing: our people get access to our EnergEyes Program, which include an annual wellbeing allowance that you can use to support your health and wellbeing including but not limited to gym memberships, fitness clothing/equipment, yoga and massage/physio sessions.
  • Birthday Reward: An additional day of paid leave just for your birthday.

 

Continue the conversation 

If you think this role might be for you and joining the CEPL family gets you excited, please submit your application as soon as possible. We will start the shortlisting process right away.

If you are shortlisted for this role, this is what you can expect throughout the process:

  • Phone screening interview 
  • Case study / task
  • Interview with a member of the People, Learning and Performance team and the Hiring Manager
  • Psychometrics test
  • Reference checks 

Please note:

  • Here at Commercial Eyes we value diversity and inclusion and consider all candidates equally.
  • Commercial Eyes does not accept applications from recruitment agencies. 
  • To apply for this role you must be a permanent resident or citizen of Australia.  

 

If you would like more information about the role, email our People, Learning & Performance department at recruitment@commercialeyes.com.au 

Employer questions

Your application will include the following questions:
  • How many years' experience do you have in a consulting role?
  • How many years of project management experience do you have?
  • Which of the following statements best describes your right to work in Australia?
  • Which of the following Microsoft Office products are you experienced with?

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