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
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
Health insurance
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 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.
Churchdwight · Australia