A leading global provider of specialised regulatory and development services for the pharmaceutical, biotechnology, and medical device industries.
The organisation supports clients across the full product lifecycle, including regulatory strategy, product development, market authorisation, and post-approval lifecycle management.This role can be based anywhere in Australia.About the RoleAn experienced Regulatory Affairs qualified role within a consulting company in Australia.
This role offers the opportunity to work with a diverse portfolio of pharmaceutical and healthcare clients, providing both strategic and operational regulatory support across Australia and New Zealand.
You will play a key role in ensuring regulatory compliance, supporting marketing authorisations, and driving successful product approvals and lifecycle management activities.
This position requires strong consulting capability, stakeholder engagement, and the ability to manage multiple client projects in a fast-paced environment.ResponsibilitiesManage regulatory submissions and lifecycle maintenance activities across Australia and New ZealandEnsure compliance with TGA and Medsafe regulations, industry standards,



and internal policiesDevelop and implement regulatory strategies to support product approvals, variations, and market expansionsProvide expert regulatory advice to clients on new and existing pharmaceutical and healthcare productsPrepare, review, and coordinate regulatory submission dossiersLiaise with regulatory authorities, including the TGA, and manage responses to queries and RFIsCollaborate with internal teams, global stakeholders, and external subject matter expertsManage multiple projects concurrently while ensuring timely delivery of regulatory outcomesQualificationsBachelor's degree in Pharmacy, Life Sciences, or a related disciplineMinimum 5+ years' experience in Regulatory Affairs within the pharmaceutical, healthcare, or consulting environmentRequired SkillsStrong knowledge of TGA and Medsafe regulatory frameworksExperience managing regulatory submissions, approvals, and lifecycle activitiesExcellent project management and stakeholder engagement skillsAbility to work independently in a fast-paced, client-facing consulting environmentStrong communication skills and a collaborative mindset
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📌 Senior Regulatory Manager (Melbourne)
🏢 i-Pharm Consulting
📍 Melbourne