Reporting directly to the Manager, Regulatory Affairs, the Regulatory Affairs Associate – Compliance is responsible for strategy and life-cycle management of all cannabis license activities and lifecycle management across Aleafia sites. They provide interpretation and risk-impact analysis on updated regulatory guidelines/policies/regulations and delivers training/communication, as needed. The incumbent liaises with internal and external partners and regulatory bodies for license lifecycle management. They are responsible for continuous improvement in the compliance space across Aleafia sites.
ESSENTIAL FUNCTIONS
- Identify regulatory submission pathways and data requirements for new license and amendment submissions.
- Compile licence submissions (new submissions, site changes requiring approval), and responses to ensure timely approvals.
- Provide interpretation and risk-impact analysis on updated regulatory guidelines/policies/regulations and deliver training as needed (Cannabis Act and Regulations, other domestic and international regulations).
- Lead continuous improvement activities to maintain best practices under the provisions of the Cannabis Act and other relevant regulations.
- Continuously monitor regulatory trends from relevant regulatory bodies and act on those to ensure continued compliance.
- Lead and actively participate in inspection/audit process flow procedure, responses and communications with internal partners and authorities.
- Assist with all regulatory/compliance reporting requirements, including accurate record keeping and retention.
- Lead and manage complaint and adverse reaction handling and recall procedures.
ROLE REQUIREMENTS/ABILITIES
Experience / Education
- Degree in a relevant field (i.e. pharmaceutical, biotechnology, science, chemistry, microbiology or biology).
- Graduate Certificate in Regulatory Affairs/Quality considered an asset.
- Minimum 3 years relevant regulatory/compliance experience in a regulated environment, preferably in cannabis, health products, pharmaceutical, food (i.e. GMP, GPP, GDP environments).
- Ability to receive valid security clearance through Health Canada.
Skills & Abilities
- Excellent understanding of the Cannabis Act and Regulations, Food and Drugs Act and Regulations, GPP, GMP, GDP.
- Ability to work effectively in a team-based, cross-functional environment.
- Project management experience is an asset.
- Experience in compiling and managing regulatory submissions is an asset.
- Experience in writing and managing SOPs, change controls, non-conformance/CAPA documentation.
- Strong organizational, analytical and multi-tasking ability.
- Ability to work effectively in a team-based environment.
- Excellent written and verbal skills, capable of speaking professionally, clearly and concisely.
- Strong negotiation skills.
- Excellent understanding of international pharmacopoeia and ICH guidelines.
- Strong computer skills.
Note: The chosen applicant will be required to successfully complete reference checks and a criminal background check.
We appreciate the interest by all candidates however we will be contacting those that best fit the requirements. If you are selected to participate in the recruitment process, please inform Human Resources of any accommodations you may require. Aleafia Health will work with you in an effort to ensure that you are able to fully participate in the process.
Job Types: Full-time, Permanent
Benefits:
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Stock options
- Tuition reimbursement
- Vision care
Schedule:
- 8 hour shift
Education:
- Bachelor’s Degree (preferred)
Work remotely:
- No
