Director, Regulatory Affairs
Tilray is a federally licensed producer of medical cannabis. We are committed to setting the gold standard of care and excellence in our industry. We believe that commitment starts with a great work environment and benefits for our associates.
Looking to develop your career at the forefront of a rapidly expanding industry?
Ready to apply your talents to make a positive difference in the lives of patients across the country?
Reporting to the VP, Regulatory & Medical Affairs, the Regulatory Affairs Director oversees the global regulatory team, provides strategic direction for product registrations and new market entries in collaboration with Business Development and Global Quality teams. Creates and manages an implementation plan to achieve strategic outcomes. Monitors the regulatory landscape of global Medical Cannabis programs and adapts the implementation plan, as needed, to address changing regulatory frameworks. The incumbent will be responsible for overseeing the drafting, compiling and controlling of product quality documentation to support international Product Registration and Market Launch initiatives. The incumbent will work cross-functionally with the BD and Global Quality teams to ensure accurate communication occurs between all relevant internal stakeholders. The incumbent will be the primary contact person for communication with the Health Regulatory Authorities in target jurisdictions. The ideal candidate has deep knowledge of GMP documentation requirements, is highly organized, thinks strategically and creatively, adapts to changing priorities and demonstrates good communication, project management and problem-solving skills.
Role and Responsibilities
- Assess and stay up-to-date on regulatory requirements for medical cannabis products in new and existing markets to ensure Tilray’s product quality standards meet regulatory requirements in every market
- Evaluate all feasible pathways for product registration via medical cannabis-specific regulatory frameworks globally
- Manage the preparation of regulatory submissions, such as CTD/DMF/QOS/SmPC documents, including assembly and proper formatting of product manufacturing data and preclinical/clinical data
- Work closely with Global Quality to ensure that product manufacturing data generated for regulatory submissions comply with relevant jurisdiction-specific regulations and policies
- Define and maintain systematic collation procedures for product quality documentation in the Controlled Document Library in accordance with document control procedures
- Work collaboratively with Business Development, Global Quality and Regulatory teams to generate an up-to-date library of all documentation related to product quality
- Perform regular impact assessment reports of any regulatory changes to ensure continuous compliance with applicable regulations
- Develop and maintain excellent relations with health regulatory agencies, including timely and professional communications
- Provide GMP-related regulatory advice to other departments (Facilities, Procurement, Manufacturing, Logistics, etc.) and advise on incorporating regulatory requirements into QMS documentation.
- Review product labels and other required product documentation to ensure compliance
- S. degree in Chemistry or related science
- Regulatory Affairs Certification preferred
- 3-5 years’ experience interacting with health regulatory agencies, preferably with international experience
- Strong scientific knowledge of drug product Chemistry, Manufacturing and Controls (CMC) documentation requirements
- Experience implementing and maintaining quality management systems and programs (ISO9001, GMP, HACCP, ACMPR, and EU GACP, GMP, GDP requirements)
- Strong understanding of regulatory requirements for international transfer of controlled substances
- Excellent management and interpersonal communication skills
- International experience preferred
- Travel required, approx. 30% time
Please apply at https://www.linkedin.com/jobs/view/1317991397
Job posted: 2019-06-18