Regulatory Affairs

Senior Regulatory Affairs Associate

• Sydney
• Competitive salary package + company benefits

Benefits • Hybrid working model with flexibility  • High-impact role with real ownership and visibility • Work with a high performing global company during a critical growth phase   About the company With a strong global footprint, this organisation operates in a highly specialised pharmaceutical space with a growing pipeline. Locally, the team is intentionally lean, creating an environment where individuals have real ownership, visibility, and impact. The business is preparing for its next phase of growth with multiple products moving through key regulatory milestones.   About the opportunity This is a senior Regulatory Affairs role within a lean, high-performing local team, created to provide immediate, hands-on regulatory support. The focus is on delivering high-quality regulatory outcomes across pre-submission and submission activities in a fast-moving environment. You’ll work closely with the Director of Regulatory Affairs taking end-to-end ownership of CAT 1 applications, pre-submission work, and dossier preparation. You’ll lead local regulatory activities while collaborating with global teams to ensure high-quality, timely submissions.   Duties • Lead and support pre-submission and submission activities with the TGA • Manage CAT 1 applications end to end • Prepare, review, and coordinate regulatory dossiers • Act as a key local regulatory contact with the TGA • Support multiple products transitioning from pre-submission into submission • Balance priorities across a significant workload while maintaining quality and momentum • Collaborate with local stakeholders and limited global teams   Skills and experience • Proven hands-on experience managing CAT 1 applications with the TGA • Strong technical regulatory writing capability, including dossier preparation • Comfortable operating autonomously in lean regulatory environments • Experience managing multiple products in parallel • Strong communication and stakeholder management skills • Adaptable, proactive, and confident in decision making   Culture Foster a collaborative, hands-on, and adaptable culture where ownership and accountability are valued. This team operates with limited resources, so confidence, energy, and the ability to roll up your sleeves are essential. Team and culture fit are as important as technical capability.   How to apply Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com   About Healthcare Professionals Group Healthcare Professionals Group recruits across executive, permanent, and contract roles within Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care, spanning Medical Affairs, Regulatory, Commercial, Operations, and Clinical functions.