This position will report to the Sr Director, Regulatory Affairs & Quality Assurance, and will be part of our Client’s regulatory and quality assurance leadership team. The Director, Regulatory Affairs will act as the primary point of contact with Health Canada and other regulatory bodies and will bear ultimate responsibility toward ensuring the organization’s regulatory compliance to cannabis regulation.
The incumbent provides strategic direction for licensing, amendments, product registrations, and new market entries in collaboration with Business Development and Quality teams. Creates and manages an implementation plan to achieve strategic outcomes while monitoring the regulatory landscape of global Recreational and Medical Cannabis programs and adapts the implementation plan, as needed, to address changing regulatory frameworks.
Responsibilities:
- Assess and stay up to date on regulatory requirements for licensing, amendments, as well as recreational and medical cannabis products in new and existing markets to ensure Client’s product quality standards meet regulatory requirements in every market.
- Accountable for providing regulatory assessments for business development/ product acquisition projects.
- Evaluate and lead the licensing and amendment strategy for growth and development.
- Evaluate all feasible pathways for product registration via recreational and medical cannabis-specific regulatory frameworks globally.
- Manage the preparation of regulatory submissions, including licensing, amendments, assembly, and proper formatting of product manufacturing data and preclinical/clinical data.
- 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. 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.
- Provide regulatory strategic input for product evaluation and prioritization.
- Work cross-functionally with the BD and Quality teams to ensure accurate communication occurs between all relevant internal stakeholders.
- Act as primary contact person for communication with the Health Regulatory Authorities in target jurisdictions.
- 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.
Knowledge & Skill Requirements:
- 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.
- Demonstrated ability to coordinate global activities, work in cross-functional teams, and supervise internal & external teams.
- Experience with communicating the regulatory strategies, issues, and risks in written and verbal format to executive team and other governing bodies.
- Strong interpersonal skills; proven track record of staff management and effective leadership.
- Demonstrated ability to manage several projects simultaneously.
- Can manage uncertainty and shifting priorities and timelines.
- Demonstrated learning agility.
- Demonstrated ability to make decisions even in the absence of complete information.
- Excellent organizational and time management skills.
- Demonstrated track record of driving performance and leadership ability within a team environment.
- Travel required, approx. 20% time
Education & Qualifications:
- Ten years of progressive experience in a related field.
- 3-5 years’ experience interacting with health regulatory agencies, preferably with international experience.
- Experience in the cannabis industry with an in-depth knowledge of the Cannabis Act.
- MBA or an advanced degree in business administration, management, organizational development, or a related field.
- Regulatory Affairs Certification preferred.
Job Type: Full-time
Salary: $0.00 per year
Benefits:
- Extended health care
Schedule:
- 8 hour shift
