Quality Regulatory Specialist
Tilray is a global leader in medical cannabis research and production dedicated to providing safe, consistent and reliable therapy to patients. We are the only GMP certified medical cannabis producer currently supplying products to thousands of patients, physicians, pharmacies, hospitals, governments and researchers in Australia, Canada, the European Union and the Americas. Our team of PhD scientists, botanists and master horticulturists are leaders in cannabis research and related agricultural sciences. We strive to improve scientific understanding of the potential applications of medical cannabis and have invested in developing continuing medical education programs for health care practitioners around the globe.
Looking to develop your career at the forefront of a rapidly expanding industry?
Ready to apply your talents to make a positive difference.
Reporting to the Quality Manager, the Quality Regulatory Specialist 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 all Portuguese regulation about Cannabis, and EU GACP, GMP, GDP and GVP requirements. The incumbent will also be responsible for drafting, compiling and controlling product development documentation to support national and international Product Registration and Market Launch initiatives. The incumbent will be the primary contact person for communication with the national Authorities and will work coordinated with the global regulatory team. The ideal candidate is highly organized, has good regulatory strategic thinking, can adapt to changing priorities and demonstrates good communication, project management and problem-solving skills managing regulatory compliance activities.
Role and Responsibilities
- Very good knowledge about controlled substances and cannabis related national and international regulations
- Assess regulatory environments and requirements of new jurisdictions and markets to ensure product quality is maintained throughout the entire product life cycle
- 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 in compliance with the Portuguese and international regulations (mainly the European) 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
- 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, as foreseen in Article 83 of Directive 2001/83/EC
Qualifications and Education Requirements
- B.Sc. degree in Pharmacist/Biological/Life Sciences/Bio engineering (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 with GMP Quality Management System
- Knowledge and experience in regulatory submissions of Herbal Medicinal Products
- Knowledge of the Portuguese Regulations, Food and Drugs Act, Controlled Drugs and Substances Act
- Strong understanding of regulatory requirements for movement of controlled/uncontrolled products between different global jurisdictions
- Thorough knowledge of Portuguese and EU regulations as well as ability to interpret policies and guidelines
- Strong scientific knowledge in analytical, manufacture and controls background is an asset
- Experience implementing and maintaining quality management systems and programs (ISO9001, GACP, GMP, HACCP) is an asset
- Proficiency in English; additional languages are an asset