Compliance Associate - Regulatory Affairs
- Paris, ON | Full-time
Reporting directly to the VP Quality & Regulatory Affairs, the Compliance Associate is responsible for strategy and life-cycle management of all cannabis licenses of Aleafia. The compliance Associate provides 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 licenses. He/she is responsible for continuous improvement in compliance space.
- Identify regulatory submission pathways and data requirements for new license and amendment submissions.
- Compile submissions and responses to ensure timely approvals.
- Provide interpretation and risk-impact analysis on updated regulatory guidelines/policies/regulations and deliver training as needed (GMP and Cannabis act)
- Lead improvement activities within daily function to maintain best practices for the provisions of the Cannabis Act and other regulations
- Continuously monitor regulatory trends from relevant regulatory bodies and act on those to ensure continued compliance
- Lead complaint and recall processes
- Lead inspection responses and communication with authorities
- Actively participate in internal and external audits and inspections
- Assist with all reporting requirements, including accurate record keeping, as outlined within the different regulations
Experience & Education Requirements
- Degree in a relevant field (i.e. pharmaceutical, biotechnology, science, chemistry, microbiology and biology).
- Minimum 3 years relevant regulatory/compliance experience in a regulated environment (preferably GMP compliant).
- Ability to receive valid security clearance through Health Canada (valid security clearance, ACMPR or CR, is considered an asset).
Skills & Abilities
- Excellent understanding of the various Cannabis Regulations and GMP.
- Ability to work effectively in a team-based environment.
- Project management experience is an asset.
- Strong computer skills.
- Strong organizational, analytical and multi-tasking ability.
- Excellent written and verbal skills, capable of speaking professionally, clearly and concisely.
- Excellent understanding with international pharmacopoeia and ICH guidelines.
- Strong negotiation skills.
Note: The chosen applicant will be required to successfully complete background and reference checks.
We appreciate the interest by all candidates however we will be contacting those that best fit the requirements.
Aleafia Health welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.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.