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 Role

An experienced Regulatory Affairs skilled 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 solid consulting capability, stakeholder engagement, and the ability to manage multiple client projects in a quick-paced environment.

Responsibilities
Manage regulatory submissions and lifecycle maintenance activities across Australia and New Zealand
Ensure compliance with TGA and Medsafe regulations, industry standards, and internal policies




Develop and implement regulatory strategies to support product approvals, variations, and market expansions
Provide expert regulatory advice to clients on new and existing pharmaceutical and healthcare products
Prepare, review, and coordinate regulatory submission dossiers
Liaise with regulatory authorities, including the TGA, and manage responses to queries and RFIs
Collaborate with internal teams, global stakeholders, and external subject matter experts
Manage multiple projects concurrently while ensuring timely delivery of regulatory outcomes

Qualifications
Bachelor's degree in Pharmacy, Life Sciences, or a related discipline
Minimum 5+ years' experience in Regulatory Affairs within the pharmaceutical, healthcare, or consulting environment

Required Skills
Strong knowledge of TGA and Medsafe regulatory frameworks
Experience managing regulatory submissions, approvals, and lifecycle activities
Excellent project management and stakeholder engagement skills
Ability to work independently in a fast-paced, client-facing consulting environment
Strong communication skills and a collaborative mindset
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📌 Senior Regulatory Manager Melbourne
🏢 i-Pharm Consulting
📍 Melbourne