This is a full-time, on-site position based at the company’s head office.

I-Pharm is partnering with a leading Australian-based pharmaceutical company known for its commitment to delivering high-quality healthcare products. This organisation is recognised for its innovative approach and strong focus on meeting the needs of consumers and healthcare providers.

They are currently seeking a dedicated Regulatory Affairs Associate to join their growing Regulatory Affairs team. Reporting to the Regulatory Affairs Senior Manager, this role offers the opportunity to contribute to regulatory excellence and support business growth across a diverse and rewarding product portfolio.

If you have experience in regulatory affairs, particularly with prescription medicines, and are looking to expand your expertise across varied therapeutic areas, this permanent full-time position presents an exciting career opportunity.

Responsibilities:

Review and refine regulatory dossiers before submission.

Prepare and submit Category 1 applications in Australia and New Zealand.

Manage responses to TGA s31 questions and variation applications (SAR, SRR, Category 3, etc.).

Compile and submit Module 1 elements (e.g., product information, labels, risk management plans).

Work closely with global affiliates and local teams on submissions.

Publish dossiers and variations using eCTD software.

Provide regulatory advice and ensure timely, high-quality submissions.

Stay updated on regulatory changes and industry trends.

Skills:

Education: A minimum of a Bachelor’s degree in Pharmacy or a Life Science discipline.

Regulatory Experience: At least 2 - 4 years in regulatory affairs within the Australian prescription pharmaceutical industry.

TGA Submissions: Proven experience in end-to-end submission of Category 1 applications.

Regulatory Knowledge: Strong understanding of Australian and New Zealand medicine regulatory requirements and processes.

Product Development Insight: Familiarity with new product development and commercialisation processes.

Apply directly now, or send your updated CV to Ben Byrne at [email protected] OR (04) 21776703

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Life Sciences industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.