Regulatory Affairs Manager | OTC
vor 2 Wochen
Regulatory Affairs Manager | OTC & Pharmaceutical | North Sydney North Sydney, NSW A$150,000-$170,000 p/a + Super Hybrid Posted 2 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. 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 (3.6 FTE) and the quality function (1 FTE) Oversee preparation, review, and submission of regulatory applications (Rx, OTC, medical devices) 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 (Rx & OTC; devices beneficial) 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 Work from home every Friday Extra day off for your birthday Fun, social workplace with a modern office close to public transport This is your opportunity to make your mark with a company shaping the future of healthcare. Contact Ashton Miller for more information on / #J-18808-Ljbffr
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Regulatory Affairs Manager – OTC
vor 2 Wochen
Council of the City of Sydney, Österreich Xprt Dev VollzeitA major pharmaceutical company in North Sydney is looking for a Regulatory Affairs Manager to lead a high-performing team. This role involves developing regulatory strategies, overseeing submissions to regulatory authorities, and ensuring compliance. The ideal candidate will have over 5 years of experience in Regulatory Affairs and a deep understanding of...
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Vor 7 Tagen
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Regulatory Affairs Product Manager
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Council of the City of Sydney, Österreich Kimberly-Clark Corporation VollzeitRegulatory Affairs Product Manager page is loaded## Regulatory Affairs Product Managerlocations: Australia – North Sydneytime type: Full timeposted on: Posted Todayjob requisition id: Regulatory Affairs Product Manager## **Job Description**People have looked to **Kimberly-Clark** brands for more than 150 years and today we're proud to help over a billion...
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Council of the City of Sydney, Österreich Johnson & Johnson Innovative Medicine VollzeitJoin to apply for the Manager, Regulatory Affairs, APAC role at Johnson & Johnson Innovative Medicine . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal....
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vor 3 Wochen
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Sydney, Österreich Biomedica VollzeitBioMedica is an Australian owned company that is dedicated to quality, purity and to formulating the most efficacious practitioner-only natural medicine products available. Equally, as ‘The Practitioner Company ’ we are dedicated to preserving and enhancing the role of the professional holistic practitioner. Position overview A newly created position,...
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Regulatory Affairs Product Manager
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Council of the City of Sydney, Österreich KE Select VollzeitA global leader in clinical diagnostics is looking for a Regulatory Affairs Manager in Sydney, Australia. The successful candidate will ensure regulatory compliance with TGA and other bodies, manage key relationships, and develop regulatory plans. Applicants should have over 5 years of experience in regulatory affairs and a Bachelor's Degree or higher....
