In-Demand Senior regulatory affairs specialist Jobs in Strathfield, Nsw

Senior Regulatory Affairs Specialist
Church & Dwight —Sydney NSW
- Full-time
- Hybrid work
- Microsoft Excel
- AI
- Health insurance
4d
Senior Regulatory Affairs Specialist
Fresenius Medical Care —Macquarie Park NSW
- Full-time
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Senior Manager, Regulatory Affairs
Cencora —North Sydney NSW
- Full-time
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- Master's degree
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Senior Specialist, Medical Science Liaison
Organon —Sydney NSW
- Full-time
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Solventum —North Ryde NSW
- Full-time
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EBOS Group —North Ryde NSW
- Full-time
- Hybrid work
- Health insurance
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BBC —North Sydney NSW
- Full-time
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Senior Regulatory Affairs Specialist
Church & Dwight —Sydney NSW
This role plays a key part in ensuring products are compliant across the full lifecycle—from development and registration through to post-market compliance—…
4d
Senior Regulatory Affairs Specialist
Fresenius Medical Care —Macquarie Park NSW
Maintain regulatory compliance across all ANZ device and medicine related pre- and post- marketing activities for the 3 key business areas.

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Senior Regulatory Affairs Specialist

Church & Dwight -
Sydney NSW

Apply Now

Job Details

Full-time
4 days ago

Benefits

Health insurance

Qualifications

Microsoft Excel
Pharmacy
AI

Full Job Description

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.

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.

Key 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

Must Have

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/

Apply Now

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