Regulatory Affairs Manager | Prescription Medicine | Remote Working
Location: Melbourne, VIC
Domain: Healthcare & Medical → Pharmaceuticals & Medical Devices
Work: Remote
Posted 3 days ago
Are you a regulatory leader ready to shape the future of a fast-growing pharmaceutical brand? Do you thrive in environments where your expertise influences strategy, quality, and compliance at a national level?
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
* 5+ 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
* Understanding of pharmacovigilance requirements
* 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 0478 156 151 /
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