Regulatory Affairs Specialist

About the Role

As a Regulatory Affairs Specialist (7-month Parental Leave Cover), you'll be responsible for leading Therapeutic Goods Administration (TGA) regulatory submissions for Over the Counter (OTC) medicines and medical devices and providing regulatory support across the full product lifecycle ensuring our products meet all relevant regulatory requirements in Australia. You'll work closely with cross-functional teams including R&D, Quality, and Marketing to support product registrations, compliance documentation, and regulatory submissions.

Key Responsibilities

• Prepare, submit, and manage regulatory submissions with the TGA.
• Maintain up-to-date knowledge of relevant regulations and standards.
• Liaise with regulatory authorities and respond to queries.
• Support product lifecycle management including variations and renewals.
• Review and approve product labelling, advertising, and promotional materials.
• Compile regulatory dossier and lodge TGA submissions, including new product applications and change applications for medical devices and registered OTC medicines.
• Provide regulatory impact assessment for changes related to products and submit TGA change applications as required.
• Collaborate with internal teams to ensure regulatory compliance across operations.

About You

• Tertiary qualification from an accredited institution in science, pharmacy, or a related field.
• 5+ years' experience in regulatory affairs (pharma, medical devices, or FMCG).
• Strong understanding of TGA and international regulatory frameworks with a demonstrated track record in leading TGA regulatory submissions for medical devices (Class I, IIa, IIb, IVD) and registered OTC medicines.
• Strong knowledge of international regulatory frameworks, e.g. EU CE MDD/MDR, FDA 510(k), MDSAP, ISO 13485.
• Excellent attention to detail and organisational skills.
• Strong communication and stakeholder engagement abilities.
• Ability to work independently and manage multiple priorities.
• Must have current Australian work authorisation at the time of application.

Why Join Us?

• Competitive salary
• Hybrid work environment
• Supportive and collaborative team culture.
• Opportunities for professional development and career growth.
• Make a real impact in a company that values quality and innovation.

About Church and Dwight

Established in 1846 and headquartered in Ewing, New Jersey, Church & Dwight is among the fastest-growing companies in the global consumer packaged goods (CPG) industry. As a trusted leader in household and personal care products, we proudly manufacture iconic brands such as ARM & HAMMER, Curash, Batiste, Decorub, First Response, Nair, OxiClean, and Orajel.

Our Culture

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.