Position:  Director, Regulatory Affairs
Location:  San Francisco, CA
Job Id:  715
# of Openings:  1

Director, Regulatory Affairs
 
Tilray produces and delivers exceptional medical cannabis products that are clean and offer consistent potency and effects to our patients. We are committed to setting the gold standard of care and excellence in medical cannabis. Our objective is to establish and maintain the market-leading standard of care and excellence for purity, potency, effects, and product availability.
 
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?
 
What You Will Be Doing:
 
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.
 
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
Qualifications:
  • Ph.D. degree in Chemistry or related science; or B.S. degree with equivalent work experience
  • Regulatory Affairs Certification preferred
  • 5-8 years’ experience interacting with competent authorities/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
  • Strong management and interpersonal communication skills
  • International experience preferred
  • Travel required, approx. 30% time
The job posting highlights the most critical responsibilities and requirements of the job. It’s not all-inclusive. There may be additional duties, responsibilities and qualifications for this job.
 
Tilray offers a culture that fosters inclusion and respect. We are an equal opportunity employer that considers applicants for all positions on the basis of merit, qualification and business needs. We recognize that our future success depends on the perspectives and contributions of all our employees -- their diverse backgrounds, abilities and experiences make our business stronger.
 
Tilray is one of the largest and most sophisticated producers of premium medical cannabis in the world. We are dedicated to providing safe, consistent and reliable medication to patients. As regulations evolve, we are well-positioned to bring our expertise to help launch mature and professional medical cannabis markets.
 
EXPERIENCE
Tilray is the only American-owned company to be a federally licensed producer of medical cannabis. In less than a year we built a $30 million, 60,000 sq ft. state-of the art research and production facility and assembled an industry-leading team of more than 120 experts.
 
PRECISION
Tilray's cultivation and processing practices are the most advanced in the industry. We are currently cultivating 40,000+ plants representing 50+ strains. Our products are tested for potency and purity before being safely packaged and clearly labeled for patients.
 
RESEARCH
We are committed to scientific research. We are actively partnering with leading physicians, hospitals and universities to advance the scientific understanding of the therapeutic value and clinical applications of cannabinoids.
 
CARE
Tilray proudly supplies thousands of patients with a range of medical cannabis products. We take pride in our customer service, patient outreach, and physician interaction. We are determined to serve medical cannabis patients around the world.
 

Apply for this Position
Go back to the job list