Senior Manager Regulatory Affairs

Job Description

Job location: Anywhere in Australia (Remote) Hours: 38 hours per week, Monday – Friday About us: We’re MedReleaf Australia – a leading provider of alternative medicine in Australia, dedicated to improving the lives of others. We’re paving the way for the industry with a talented team of professionals who help introduce holistic healthcare solutions across Australia. About you: Plant your roots with us as our next Director Regulatory Affairs where you will play a critical leadership role overseeing regulatory compliance, public policy development, and other strategic initiatives critical for MedReleaf Australia’s operations in Australia and New Zealand. As the Director Regulatory Affairs you will oversee… Regulatory Leadership and Strategy Develop and oversee the execution of comprehensive regulatory strategies to support product development, registration, licensing, and approval processes across ANZ. Ensure ongoing compliance with local, national, and international regulatory requirements. Act as a strategic advisor on regulatory matters, collaborating with senior leadership to align regulatory priorities with business goals. Monitor and evaluate regulatory trends and provide forward-looking guidance to anticipate and address potential challenges. Public Policy Development Collaborate with colleagues to support the development and implementation of government relations strategies to influence government policies, regulations, and legislation supporting the growth of the medicinal cannabis industry in the ANZ market. Leverage opportunities to support MRA/Aurora’s participation in local/regional industry associations or related special events. Collaborate with internal teams, including Legal, Regulatory, and Quality Assurance, to ensure government relations efforts are aligned with organizational objectives. Team Oversight and Cross-Functional Collaboration Lead, mentor, and manage the Regulatory Affairs and Compliance team across ANZ. Collaborate with R&D, Quality Assurance, Legal, and other teams to integrate regulatory considerations into product development, manufacturing, and marketing activities. Provide training to internal stakeholders on regulatory changes and ensure organizational readiness for compliance. Regulatory Operations and Agency Engagement Serve as the primary interlocutor with regulatory authorities, managing all submissions, queries, and inspections. Oversee the preparation and submission of regulatory documentation, ensuring accuracy and adherence to timelines. Build and maintain strong relationships with regulatory agencies. Compliance and Risk Management Oversee the implementation and maintenance of the Quality Management System (QMS). Manage all relevant licenses, permits, and certifications. Conduct internal audits and risk assessments. Operational Excellence and Continuous Improvement Lead initiatives to optimize the Business’ SAS program, Portal rollout, and CSO network expansion. Oversee the review and approval of product labeling, barcodes, and packaging materials. You’ll be set up for success if you have… Bachelor’s degree in Law, Regulatory Affairs, or a related field. 8+ years of progressive experience in regulatory affairs, compliance, and quality management. Proven success in preparing and submitting regulatory documents for product approvals. Demonstrated experience working with regulatory authorities. This role requires travel, schedule flexibility, and a satisfactory Police and Reference Check. Next steps: Submit your resume through LinkedIn by clicking “Apply Now”. Your application will be sent to our Human Resources Team and if we think you’re a fit, we will contact you via email. Seniority level Director Employment type Full-time Job function Legal, General Business, and Management Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr