Consultant, Regulatory Affairs And Operations
2 weeks ago
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.
Deliver smarter, faster regulatory solutions across Australia and New Zealand.
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.
Post-graduate qualifications in a relevant discipline, desirable.
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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