Regulatory Affairs Associate

Regulatory Affairs Associate – Fixed-Term Contract until the end of June 2026.Join a leading pharmaceutical company shaping the future of aestheticsAbout the Company Our client is a global pharmaceutical leader in the aesthetic injectable market, known for delivering science-driven innovation and high-quality products that empower both healthcare professionals and patients. With a culture that values collaboration, agility, and continuous learning, this organisation offers an inspiring environment where you can make a real impact. They have a portfolio of injectable prescription aesthetic products and medical devices.About the RoleAn exciting opportunity has arisen for a Regulatory Affairs Associate to join the Australian team on a fixed-term contract until June 2026 (hopefully with a view to a permanent position once headcount is approved). Reporting to the Regulatory Affairs Manager, you will play a key role in ensuring compliance with regulatory requirements and supporting product registrations and lifecycle management activities across the aesthetic injectable and capital equipment portfolio.Key ResponsibilitiesPrepare, submit, and maintain regulatory documentation for product registrations, variations, and renewals in accordance with TGA requirements.Support local implementation of global regulatory strategies and processes.Maintain up-to-date knowledge of regulatory guidelines relevant to prescription medicines and aesthetic injectables.Liaise with cross-functional teams, including Quality, Medical, PV, Regulatory and Marketing to ensure compliance throughout the product lifecycle.Develop and maintain excellent working relationshipswith relevant regulatory bodies and governmentdepartments.Assist in reviewing promotional materials and ensuring adherence to local regulatory and corporate standards.Support the pharmacovigilance activities within the business, including PCQ and AEAbout You: You are a detail-oriented and proactive professional who thrives in a dynamic and collaborative environment. You bring a strong understanding of regulatory frameworks and a passion for contributing to the success of a fast-paced, science-led organisation.To be successful in this role, you will have:A tertiary qualification B.Science, B. Pharm, B.Eng (Biomed)1–3 years’ experience in Regulatory Affairs within the pharmaceutical, medical device, or related industry.At least Medical Device Conformity Assessment experience with Class III devices is required.Prescription medicine experience an advantage.Working knowledge of TGA regulations and regulatory submissions.Excellent written and verbal communication skills with strong attention to detail.Experience with Pharmacovigilance/Medicovigilance and Quality activities an advantageThe ability to manage multiple priorities and meet deadlines.Be a collaborative, agile team playerWhy Join?Work with an industry leader in the fast-growing aesthetics market.Collaborate with a high-performing and supportive team.Gain valuable experience in a global organisation with a strong reputation for innovation.Enjoy a flexible, inclusive, and development-focused culture.Competitive package including health allowanceHow to Apply If you are looking to build your regulatory career within a leading pharmaceutical company and make an impact in the aesthetics space, we’d love to hear from you.Click Apply Now to submit your application.Alternatively, call John Evans on 0418 656 468 or Maryann Bastac 0438 114 314 for a confidential discussion. www.ephealthcare.com.auPlease follow us on our LINKEDIN page; EPHealthcareWhy work with EPHealthcare?Specialists in recruitment in Pharmaceutical and Medical DevicesOutstanding network of clientsThorough knowledge of the Healthcare industryIndustry experience - as reps, managers, marketers!Personalised and experienced approach, every step of the interviewing process. This opportunity is only open to candidates who are eligible to work in Australia and hold the appropriate visa to work permanently