Consultant - Regulatory

About The RoleThe Consultant operates within the RQC function, supporting the development, preparation, and submission of regulatory applications for prescription medicines across Australia and New Zealand. This role involves managing regulatory projects from planning through execution, working collaboratively with internal teams and clients to ensure compliance with local regulatory requirements. The Consultant plays a key role in delivering high-quality regulatory outcomes, optimizing submission strategies, and contributing to the continuous improvement of regulatory processes and team capability.Key ResponsibilitiesPrepare, 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.RequirementsBachelor’s or master’s degree in pharmacy, Life Sciences, or a related field.3 to 4 years of Regulatory Affairs experience with direct involvement in prescription medicine regulatory submissions.Hands-on experience with Medsafe and/or TGA regulatory procedures, including preparation and submission of CTD dossiers.Strong project management experience in regulatory operations, with proven ability to coordinate cross-functional inputs and meet submission timelines.Sound understanding of regulatory requirements for prescription medicines across the Australian and New Zealand market.Excellent written and verbal communication skills with attention to detail.Ability to manage multiple priorities and work independently in a dynamic regulatory environment.