RA Project Manager

Lead and manage regulatory project plans for new product introductions, renewals, and lifecycle changes across Australia and New Zealand. Coordinate cross-functional regulatory activities with local, regional, and global partners (RA, R&D, Clinical, Medical, Quality, Supply Chain, Marketing). Develop and maintain detailed regulatory timelines, risk assessments, and status reporting to ensure on-time delivery. Prepare, compile, and support regulatory submissions and responses to health authority questions in accordance with TGA and Medsafe requirements. Serve as the primary regulatory project contact for assigned ANZ initiatives, proactively identifying risks and mitigation strategies. Ensure alignment of local regulatory execution with global regulatory strategies and company objectives. Track and manage regulatory commitments, post-market changes, and license maintenance activities. Support continuous improvement of regulatory project management processes, tools, and metrics within QARA International. Mentoring and technical support to Regulatory Affairs associates as required. Requirements 5+ years of experience in Regulatory Affairs, Regulatory Operations, or Regulatory Project Management within medical devices, pharmaceuticals, or combination products. Demonstrated experience managing regulatory timelines and cross-functional deliverables. Working knowledge of ANZ regulatory frameworks (TGA and Medsafe). Ability to manage multiple projects simultaneously in a matrixed, global environment. Bachelor’s degree in a scientific, engineering, or health-related discipline (e.g., Biomedical Engineering, Life Sciences, Pharmacy). Language: Fluent English (written and verbal). Core Competencies Demonstrates expertise in Regulatory Affairs and Project Management, with a strong focus on managing regulatory timelines and cross-functional deliverables in compliance with TGA and Medsafe requirements. Proficient in mentoring and providing technical support to teams while ensuring alignment with global regulatory strategies. Highest-signal resume keywords Regulatory Affairs Management Regulatory Project Management TGA Compliance Medsafe Compliance Cross-Functional Coordination ATS Optimization Keywords Hard Skills Regulatory Submissions Risk Assessment Regulatory Timelines Management Project Planning Regulatory Operations Soft Skills Mentoring Communication Problem-Solving Collaboration Industry Keywords Medical Devices Pharmaceuticals Combination Products ANZ Regulatory Frameworks Tools & Technologies Regulatory Project Management Tools Metrics Tracking Systems #J-18808-Ljbffr