Consultant, Regulatory Affairs

2 weeks ago

Melbourne, Australia Groupe ProductLife Full time

Consultant, Regulatory Affairs & Operations 347

Australia, Melbourne

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Hybrid

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Life Cycle

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Regulatory Affairs & Operations

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Permanent contract

Deliver smarter, faster regulatory solutions across Australia and New Zealand.

We’re looking for a Consultant to join our Regulatory Affairs & Operations team. Play a key role in delivering high-quality regulatory outcomes, optimising submission strategies, and contributing to the continuous improvement of regulatory processes and team capability.

About the Role

In this role, you will:

- Prepare, review, and submit regulatory dossiers to Medsafe and TGA, including New Medicine Applications (NMAs), Variations (Category 1), Notifications, product information updates, and safety-related changes.
- Ensure compliance with Medsafe and TGA regulatory frameworks and guidance (e.g., GRTP, ARGPM).
- Serve as the regulatory project coordinator for assigned submissions, tracking deliverables, timelines, and risk mitigation plans.
- Liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
- Handle lifecycle management of prescription medicines including labelling updates, renewals, and post-approval commitments.
- Respond to agency queries and deficiency letters within defined timelines.
- Maintain internal regulatory trackers, databases, and submission archives in accordance with SOPs.
- Monitor changes in local regulatory guidelines and communicate impact assessments as needed.

What You Bring

- A bachelor’s degree in science, pharmacy or a related discipline.
- A minimum of 5 years’ experience in regulatory affairs, preferably in a commercial environment.
- Experience in the review, critical evaluation and presentation of clinical data.
- Good knowledge of legislation, regulations, guidelines and working procedures within Australia, New Zealand and the JAPAC region.
- High level written and oral communication skills.
- Proven problem solving and project management skills.
- Reasonable computer literacy.
- Ability to deal with high level of confidentiality.
- Previous experience in project management and/or consulting.

Why Join Us?

- Collaborate with some of the brightest minds in regulatory affairs
- Contribute to projects that have real-world impact on patient care
- Enjoy a flexible, hybrid work model and commitment to work-life balance
- Join a company that values expertise, purpose, and progress

Ready to make a bigger impact?
Click Apply Now and make an impact in regulatory affairs across Australia and New Zealand.

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