About the Role
We are seeking a proactive and detail-oriented 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
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
- 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.
- 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
- 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
Skills
- Regulatory Affairs
- Product Compliance
- TGA Listed Medicines
- AICIS Cosmetic Compliance
- Evidence Evaluation
- Regulatory Governance
- New Zealand Regulations
- Medsafe
- EPA
- Attention to Detail
- Regulatory Accuracy
- Complex Regulation Interpretation
- Project Management
- Prioritisation
- Digital Tools
- AI
- Automation
Location
- Australia
- New Zealand
Work Type
- Hybrid
Experience Level
- 5+ years
Education Level
- Degree in Science, Pharmacy, or related discipline
Benefits
- Competitive salary
- Hybrid work environment
- Flexi Days
- Individual Health Insurance
- Supportive and collaborative team culture
About the Company
- Church & Dwight is a world-leader in household and personal care products. Our global brands include ARM & HAMMER®, Batiste, OxiClean, Trojan, XTRA, Nair, First Response, Spinbrush, Orajel, vitafusion, Li’l Critters, Water Pik and FLAWLESS®. Founded in 1846, we have operations globally and are listed in the S&P 500.
Equal Opportunity
- Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
