Regulatory Affairs Associate

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Council of the City of Sydney, Österreich EPHealthcare Vollzeit

Regulatory Affairs Associate – Fixed-Term Contract (until June 2026) A fixed‑term role (until June 2026) with the potential to become permanent. Reporting to the Regulatory Affairs Manager, you will ensure ongoing compliance with TGA requirements, support product registrations, and manage lifecycle activities across an innovative portfolio. Why you’ll love this role Genuine, supportive, and collaborative team – everyone placed here speaks highly of the culture. Exposure to diverse products – work with both prescription aesthetic injectables and medical devices. Inclusive and flexible work environment – a culture that values balance and belonging. Competitive package – includes a health allowance and other benefits. What you’ll be doing Preparing and maintaining regulatory documentation for registrations, variations, and renewals. Supporting local implementation of global regulatory strategies. Keeping up-to-date with TGA guidelines for medicines and devices. Working closely with Quality, Medical, PV, and Marketing teams. Building strong relationships with regulatory bodies and government departments. Reviewing promotional materials for compliance. Assisting with pharmacovigilance activities including PCQ and AE reporting. What we’re looking for Degree in Science, Pharmacy, or Biomedical Engineering. 1–3 years’ experience in Regulatory Affairs within pharma or medical devices. Essential: Medical Device Conformity Assessment experience (Class III). Prescription medicine experience (bonus). Strong knowledge of TGA regulations and submissions. Excellent communication skills and attention to detail. Ability to juggle multiple priorities and deadlines. Pv/Quality experience (bonus). About the Company This isn’t just another big name – it’s a business that values its people. People we’ve placed here rave about the culture: supportive, collaborative, and genuinely nice. It’s a global organisation, but the local team feels close‑knit and welcoming. How to Apply Ready to take the next step in your regulatory career? Click Apply Now or contact:Lisa Fox – ***Maryann Bastac – *** us on LinkedIn: EPHealthcare Why EPHealthcare? Specialists in Pharmaceutical & Medical Device recruitment. Extensive client network and industry expertise. Personalised support throughout the hiring process. Applicants must have full Australian work rights. #J-18808-Ljbffr



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