The Regulatory Associate, ANZ will also be responsible for drafting, compiling and controlling quality and regulatory dossiers for Product Registration and Market Launch initiatives in Australia and New Zealand
This is what you need to be able to do
Regulatory Affairs Associate, ANZ – Sydney, Australia
About Tilray
Tilray is a leading global cannabis-lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is changing people’s lives for the better – one person at a time – by inspiring and empowering the worldwide community to live their very best life by providing them with products that meet the needs of their mind, body, and soul and invoke a sense of wellbeing. Tilray’s mission is to be the trusted partner for its patients and consumers by providing them with a cultivated experience and health and wellbeing through high-quality, differentiated brands and innovative products. A pioneer in cannabis research, cultivation, and distribution, Tilray’s unprecedented production platform supports over 20 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and alcoholic beverages.
Looking to develop your career at the forefront of a rapidly expanding industry?
Reporting to Global Regulatory Affairs, the Regulatory Associate, ANZ will provide regulatory expertise to assist with the development of QMS processes and systems for integrated supply chain management through to product distribution, and intra- and international active substance, medicinal product and raw materials movements and storage, ensuring compliance with medicinal cannabis regulations, and EU GACP, GMP, GDP and GVP requirements.
The Regulatory Associate, ANZ will also be responsible for drafting, compiling and controlling quality and regulatory dossiers for Product Registration and Market Launch initiatives in Australia and New Zealand. Leading document collection and review, the incumbent is responsible for document quality and adherence to applicable regulations in collaboration with the submission and review team(s). He/ She is the point of contact for regulatory submission/ registration business partners. The incumbent will be the primary contact person for communication with the national Authorities.
Role and Responsibilities
- Manage the preparation of regulatory submissions including evaluating analytical/manufacturing, clinical and pre‐clinical data, and preparation of CTD/DMF/QOS/SmPC where required
- Ensure that scientific data supporting submissions are following domestic and international regulations and all relevant guidelines and policies.
- Assemble and maintain product development documentation systematically in the Document Library in accordance with document control procedures
- Work collaboratively with the Business Development, Global Quality and Regulatory functions to prepare and review Product Documentation
- Perform regulatory impact assessment of CMC relevant changes to ensure continuous compliance with applicable regulations
- Assess regulatory environments and requirements of new jurisdictions and markets to ensure product quality is maintained throughout the entire product life cycle
- Respond to health authority requests in a timely manner
- Provide GMP-related regulatory advice to other departments (Facilities, Procurement, Manufacturing, Logistics, etc.) and advise on incorporating regulatory requirements into QMS documentation.
- Perform internal departmental regulatory compliance audits to facilitate sustained conformance
- Review product labels or other required documentation to ensure compliance with International requirements
- Ensure that any additional requirements imposed on certain products by national regulation are adhered to
Qualifications and Education Requirements
- B.Sc. degree in Pharmacist/Biological/Life Sciences/Bioengineering (Pharmacology, Molecular Biology, Biology, Chemistry) or extensive experience and related training
- Post-Graduate Regulatory Certification considered an asset
- Minimum 5 years direct regulatory experience in drug development/ regulatory affairs or healthcare related field either national or international
- Knowledge and experience working within a pharmaceutical manufacturing, packaging, and warehousing cGMP Quality Management System
- Knowledge and experience in regulatory submissions of Herbal Medicinal Products
- Strong understanding of regulatory requirements for movement of controlled/uncontrolled products between different global jurisdictions
- Thorough knowledge of EU regulations as well as ability to interpret policies and guidelines
- Strong scientific knowledge in analytical, manufacture and controls background are an asset
- Proficiency in English; additional languages are an asset
Employer questions
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Which of the following statements best describes your right to work in Australia?
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How many years’ experience do you have as a Regulatory Affairs Associate?
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Have you worked in a role where you were responsible for authoring and reviewing technical documentation?
