Senior Regulatory Affairs Specialist

About the role

We are seeking a proactive and detail-oriented Senior Regulatory Affairs Specialist to support a diverse product portfolio across Australia and New Zealand. This role plays a key part in ensuring products are compliant across the full lifecycle-from development and registration through to post-market compliance-working closely with R&D, Quality, Marketing, and Supply Chain teams to enable compliant and timely product launches.

Responsibilities

• Prepare, submit, and manage regulatory applications and submissions to AICIS and TGA respectively for cosmetics and therapeutic goods (listed medicines, OTC medicines, and low-risk medical devices)
• Manage variations, renewals, and change applications
• Conduct regulatory assessments for new product launches including formulation, claims, labelling, IFU and product specification reviews
• Critically evaluate scientific and technical evidence to support indications and product claims
• Review and approve product advertising, and promotional materials.
• Support ongoing regulatory compliance across assigned brands
• Conduct regulatory impact assessments for product formulation, packaging, and manufacturing changes
• Maintain up-to-date knowledge of relevant regulations and standards. Monitor regulatory changes and assess impact on product portfolio in a timely manner
• Provide regulatory requirements to cross-functional teams
• Use digital tools (e.g. regulatory systems, Excel, AI and emerging technologies) to support data analysis, reporting and improve efficiency
• Identify opportunities to streamline workflows and enhance productivity
• About You

Requirements

• Degree in Science, Pharmacy, or a related discipline
• Demonstrated at least 5-year experience in regulatory affairs in TGA listed medicines (including regulatory support and lifecycle management), evidence evaluation, and AICIS cosmetic compliance
• Strong knowledge of Australian regulatory governance and frameworks
• Highly Regarded
• Exposure to additional product categories such as OTC medicines, low-risk medical devices, electrical products, food, or other FMCG
• Knowledge of New Zealand regulations, including Medsafe, EPA, etc.
• Skills & Attributes
• Strong attention to detail and regulatory accuracy
• Ability to interpret complex regulations and translate into practical guidance
• Strong prioritisation and project management skills
• Proactive, solutions-focused mindset with ability to manage multiple priorities
• Digital & AI Capability
• Comfortable using digital tools to manage regulatory data and documentation
• Interest in applying AI or automation tools to improve efficiency and quality
• Continuous improvement mindset with a focus on smarter ways of working
• Why Join Us?
• Competitive salary
• Hybrid work environment
• Flexi Days
• Individual Health Insurance
• Supportive and collaborative team culture.
• Work across a diverse and dynamic product portfolio
• Make a real impact in a company that values quality and innovation.
• #LI-Hybrid
• Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
• For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/

Benefits

Additional Information

A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries. United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win. We're seeking a detail-oriented and proactive Senior Regulatory Affairs Specialist to join our dynamic team at Church and Dwight Australia . This is a fantastic opportunity for someone passionate about regulatory and product compliance and driving quality outcomes in a fast-paced environment.

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