Senior Regulatory Affairs Specialist at Church & Dwight Co., Inc. | Sydney, Australia | Rezi

Senior Regulatory Affairs Specialist at Church & Dwight Co., Inc.

Senior Regulatory Affairs Specialist

Church & Dwight Co., Inc. · Sydney, Australia

1 months ago

Senior Regulatory Affairs Specialist

Church & Dwight Co., Inc. · Sydney, Australia

2 months ago
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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.