This is your chance to join a major force in the pharmaceutical industry during an exciting phase of growth and transformation.
The Company
Our client is a market-leading pharmaceutical company known for high-quality prescription, biosimilar, and OTC products. With strong partnerships across major retailers like Chemist Warehouse, Priceline & Coles as well as independents, they are rapidly expanding their footprint across Australia and New Zealand. They continue to set the benchmark for innovation and excellence.
They are a true industry leader — a household name — where purpose, belonging, and innovation drive everything they do. This is a place where your expertise has real influence, your decisions matter, and your career can thrive.
The Opportunity
We're seeking an experienced Regulatory Affairs Manager to lead a high-performing team and oversee regulatory strategy across a diverse pharmaceutical portfolio.
In this pivotal role, you will manage regulatory associates, own end-to-end submissions, guide compliance activities, and partner closely with internal and external stakeholders across Australia and New Zealand.
You'll play a key role in shaping regulatory direction, ensuring high-quality submissions, maintaining compliance, and supporting major new product launches.
Key Responsibilities
* Lead and mentor a team of regulatory associates (3.0 FTE) and the quality function (1 FTE)
* Oversee preparation, review, and submission of regulatory applications to the TGA and Medsafe
* Develop regulatory strategies for new medicine submissions
* Maintain regulatory documentation to ensure compliance across assigned products
* Collaborate with manufacturers, licensing partners, and internal stakeholders
* Manage deficiency responses to regulatory authorities
* Develop and maintain PI, CMI, labels, and Certified Product Details
* Support regulatory and quality activities for new product launches
* Review Quality and Pharmacovigilance agreements for compliance
* Ensure marketing materials meet regulatory and TGA advertising standards
* Build and maintain systems, SOPs, documentation, and quality processes
* Oversee lifecycle maintenance including variations, change controls, and impact assessments
* Manage GMP clearance submissions and ongoing compliance
* Build strong relationships with the TGA and key external partners
* Stay updated with regulatory changes and intelligence
* Lead departmental projects and continuous improvement initiatives
What You'll Bring
* Degree in Pharmacy, Science, Chemistry or related field
* 7+ years' experience in Regulatory Affairs - prescription medicine experience desired. Devices experience a bonus.
* Strong team leadership experience desirable
* Deep understanding of Australian and NZ regulatory frameworks
* Experience in quality assurance systems and compliance (desired not essential)
* Understanding of pharmacovigilance requirements (desired not essential)
* Advanced analytical, problem-solving, and communication skills
* Ability to manage deadlines, multitask, and collaborate effectively
Why You'll Love Working Here
* Fast-paced, agile environment where your ideas genuinely matter
* Direct access to decision-makers — no corporate red tape
* Supportive culture built on collaboration and authenticity
* Extra day off for your birthday
This is your opportunity to make your mark with a company shaping the future of healthcare. Contact Ashton Miller for more information on /