Senior Regulatory Affairs Associate (Canada)

Description

• Provide timely and appropriate reports to the Director, Canada Regulatory Affairs.
• Manage and perform the activities to ensure compliance with internal and external standards and requirements.
• Establish and maintain professional standards of communication with colleagues within and outside the organization.
• Keep abreast of changes in regulatory requirements to legislation, regulations, and guidances and provide reports about how the proposed changes may impact the organization's activities.
• Interact with other departments for the timely launch of products especially with respect to regulatory issues and to ensure the appropriate information is obtained for submissions.
• Prepare and submit high quality site submissions and product submissions (i.e., registration, amendments, and renewals or similar) in compliance with the regulatory requirements for the relevant markets within scheduled timeframes.
• Review relevant documents (e.g., product labels, study protocols and reports, change controls, deviations, complaints, etc.) to support compliance and product launches.
• Prepare and submit the monthly cannabis inventory and sales reports and other reports as required under the federal Cannabis Act and its Regulations and related provincial/territorial regulations within regulated timeframes.
• Prepare and submit import and export permit applications and shipment notifications.
• Prepare and maintain product information documentation for products.
• Prepare and submit recycling reports and other reports as required under the applicable federal and provincial regulations related to Extended Producer Responsibility (EPR) requirements.
• Manage and maintain up to date trackers for various subject matters for the department.
• Conduct presentations and/or training to promote regulatory compliance within the organization.
• Perform other duties as assigned.

• Bachelor’s degree or equivalent in Chemistry, Biology, Food Science, or similar.
• 2+ years’ experience in the cannabis industry or adjacent field in the pharmaceutical or food industry within Regulatory Affairs, with focus on process development or manufacturing and preparation of submission documentation.
• Experience in the cannabis industry, with a strong understanding of the federal Cannabis Act and its Regulations and demonstrated experience on the application of these regulations in daily tasks, is considered an asset. Demonstrated experience with provincial and territorial cannabis related legislation, regulations, and guidance.
• Must possess a passion for cannabis products and services and the cannabis industry in general, while providing sound regulatory advice in line with the current regulations.
• Proven ability to apply critical thinking in regulatory assessments, innovating and solving complex problems efficiently and effectively.
• Strong verbal and written communication skills with the ability to convey regulatory assessments clearly to both technical and non-technical audiences, and presentation abilities to share information with diverse groups.
• Ability to adapt to a rapidly changing corporate focuses and industry dynamics, being flexible and efficient in the fast-paced industry environment.
• Well-versed in Microsoft Office (Word, Powerpoint, Excel) and familiarity with IT systems (e.g., electronic submission systems (Cannabis Tracking and Licensing System (CTLS)), data and document management systems).
• Excellent at working with internal and external stakeholders, driving decision-making and collaboration.
• Exceptional attention to detail with excellent time management skills.