Senior Manager Regulatory Affairs

Director Regulatory AffairsDivision: MedReleaf AustraliaJob location: Anywhere in Australia (Remote)Hours: 38 hours per week, Monday – FridayEmployment type: Full-time permanent role operating remotelyAbout 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. Together, we’ve defined what we call the MedReleaf Way - a secret recipe for success that allows us to be a trusted provider, educator, and leader in the industry for our community - and this is what makes us a special place to work.

We’re in an exciting period of growth and are on a mission to expand our team across Australia with a range of dynamic opportunities. We’re now part of a global network of Aurora Cannabis, a world-leading integrated medical cannabis company with a strong reputation for setting the global standard in alternative medicine care. With a strong presence in markets including Canada, Europe, Australia, and New Zealand, Aurora brings invaluable expertise that will support our growth and continue to enable us to deliver exceptional patient care within our community. If this is not the role for you, check out our Global Aurora Careers Page to find the perfect opportunity.

About you:

Plant your roots with us as our next Director Regulatory Affairs where you will play critical leadership role overseeing regulatory compliance, public policy development and other strategic initiatives critical for MedReleaf Australia’s operations in Australia and New Zealand. You will be responsible for developing and executing regulatory strategies to further our regulatory and commercial interests, ensuring compliance with applicable laws and industry standards, and serving as the primary interlocutor with regulatory authorities and public policy leads, including the Ministry of Health (NZ), New Zealand Medicinal Cannabis Council (NZ), Therapeutic Goods Administration (TGA), the Office of Drug Control (ODC) and Australian Health Practitioner Regulation Agency (AHPRA).

In this role you will ensure the integrity of our products and services while driving alignment with regulatory frameworks and influencing policy to support business objectives. Critical to this role will be strengthening our position as a trusted leader in the medicinal cannabis industry and ensures sustainable growth and compliant practices across the ANZ market. Sound exciting? Here is a little more…

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

• Working within the Centre of Excellence, 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 that are focused on broadening relationships with government decision-makers, facilitating access to medical cannabis for patients, and other objectives that are in alignment with Aurora’s corporate outcomes in ANZ.
• 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 to ensure high performance and professional development.
• 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, including but not limited to Therapeutic Goods Administration (TGA), the Office of Drug Control (ODC), Australian Health Practitioner Regulation Agency (AHPRA), Ministry of Health (NZ) and New Zealand Medicinal Cannabis Council (NZ), 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, ensuring effective communication and advocacy for the organization’s interests.

Compliance and Risk Management

• Oversee the implementation and maintenance of the Quality Management System (QMS), ensuring adherence to regulatory and quality standards.
• Manage all relevant licenses, permits, and certifications, ensuring timely renewals and compliance with applicable regulations with applicable team members.
• Conduct internal audits and risk assessments, implementing corrective and preventive actions to address quality or compliance gaps.
• Ensure the timely resolution of complaints, adverse events, and quality issues in accordance with regulatory guidelines.

Operational Excellence and Continuous Improvement

• Lead initiatives to optimize the Business’ SAS program, Portal rollout, and CSO network expansion, ensuring seamless execution and compliance.
• Oversee the review and approval of product labelling, barcodes, and packaging materials to meet regulatory requirements.
• Collaborate with external partners, vendors, and industry stakeholders to ensure compliance and support regulatory reform efforts.

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, with at least 2–3 years within the pharmaceutical or medicinal cannabis industry preferred.
• Proven success in preparing and submitting regulatory documents for product approvals and managing regulatory inspections.
• Demonstrated experience working with regulatory authorities, such as but not limited to the TGA and ODC, Ministry of Health (NZ) and New Zealand Medicinal Cannabis Council (NZ), with a thorough understanding of regulatory requirements in Australia and New Zealand.
• Experience working in a global public and matrix environment, ideally in medical cannabis.
• Experience navigating complex, matrix, resource-constrained environments, managing ambiguity, and adapting to continuous change while maintaining a focus on organizational goals.

We can’t wait to meet you if you have…

• Exceptional regulatory affairs expertise with in-depth knowledge of regulatory processes, including product registration, submissions, and compliance, with a strong understanding of pharmaceutical regulations, guidelines, and quality standards, including Good Manufacturing Practice (GMP) principles. Possesses a track record of problem resolution.
• Strong communication skills for effective interaction with regulatory agencies and internal stakeholders.
• Excellent project management skills to ensure timely and accurate submission of regulatory documents.
• Strong analytical skills for interpreting and applying regulatory requirements to business processes.
• Strong judgment to evaluate options and implement effective strategies to address compliance, regulatory, and government relations needs.
• Understanding of corporate strategy, market dynamics, and how regulatory and government relations influence business objectives with experience working in matrix global environments and influencing decision-making.
• Proven ability to lead, mentor, and manage cross-functional teams, fostering collaboration and high performance.
• Competence in managing regulatory and reputational risks, ensuring effective responses to compliance or policy-related challenges.
• Demonstrated ability to lead with courage and integrity, speak truth to power, and foster collaboration to drive success, while embodying our values of Winning Together, Courage, Accountability, and Compassion in all actions
• Possesses the ability to adapt quickly , while maintaining focus and a high degree of accuracy maneuvering complex data in an environment of everchanging deadlines, priorities, and requirements

This role requires travel, schedule flexibility, and a satisfactory Police and Reference Check.

Life@MedReleaf

With us, you will find a place where you belong and love where you work with a whole crop of benefits like the following:

• Competitive Compensation: Enjoy a base salary, super, annual bonus (when applicable) and more!
• Professional Development: Unlock robust growth opportunities with access to conferences, workshops, webinars, a study support program for tuition, and career development
• Work-Life Balance: Prioritize your well-being with our flexible work structure, offering remote work options, annual and personal leave options
• Vibrant Culture: Join a dynamic team with exciting events like sales celebrations, holiday parties, volunteer initiatives, and product launches that make every day memorable

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.