Join to apply for the Senior Regulatory Affairs Associate role at Fresenius Kabi Australia and New Zealand.We are currently seeking an experienced Senior Regulatory Affairs Associate to join a highly dynamic, successful, and motivated team based in Mount Kuring-gai.Responsibilities include:Product Registration: Reviewing, compiling, and submitting registration dossiers for Australia and New Zealand, maintaining review notes, tracking correspondence with the Therapeutic Goods Administration and Medsafe, handling Category 1 and New Medicine Application submissions, and maintaining Good Manufacturing Practice evidence.Building and Maintaining Relationships: Developing relationships with industry and government officials, liaising with external experts and internal teams to ensure effective communication and project success.Administration: Preparing reports, maintaining up-to-date documentation and regulatory files for easy access and retrieval.Technical Expertise and Compliance: Keeping current with regulatory environment, attending industry conferences, and ensuring compliance with relevant laws, standards, and ethical guidelines.Requirements:Minimum 3 years of regulatory affairs experience or equivalent.Tertiary qualifications in Pharmacy, Life Sciences, or Chemistry.Knowledge of Medical/Scientific and Technical aspects.Understanding of TGA, Medsafe, and relevant industry knowledge.Experience with regulatory submissions including Category 1, Category 3, NMA, and notifications.Strong organizational, communication, and strategic planning skills.We offer a competitive salary, vehicle allowance, incentive programs, flexible work arrangements, and a focus on personal development, health, and wellbeing.About Fresenius Kabi:Fresenius Kabi is committed to advancing patient care through high-quality medicines and technologies, with a diverse and inclusive workplace that values equal opportunity and encourages applications from all backgrounds.
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