Senior Regulatory Manager

i-Pharm Consulting; City of Melbourne; On-site; AUD 120,000 - 180,000; Full time

Job summary

i-Pharm Consulting in Australia is seeking an experienced Regulatory Affairs professional to work with a diverse portfolio of pharmaceutical and healthcare clients, providing strategic and operational regulatory support across Australia and New Zealand.

You will ensure regulatory compliance, support marketing authorisations, and drive product approvals and lifecycle management in a fast-paced consulting environment.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related discipline.
• Minimum 5+ years' experience in Regulatory Affairs within pharmaceutical, healthcare, or consulting environments.

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.

Skills

Regulatory submissions

Stakeholder engagement

Project management

Independent work

Communication

Education

Bachelor's degree in Pharmacy, Life Sciences, or related discipline

Job description

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 professional 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.

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