Aleafia Health brings Canadians medical cannabis care through nationwide clinics, world-class cultivation and distribution facilities, and innovative research.
Reporting directly to the Manager, Regulatory Affairs, the Regulatory Affairs Associate is responsible for all compliance and regulatory requirements of new product introductions, from idea to launch, for both domestic and international product launches. For these new product introductions and launches they are integrated in multi functional project teams. They provide interpretation and risk-impact analysis on regulatory guidelines, policies and regulations and delivers training and communication as needed. The incumbent liaises with internal and external partners and regulatory bodies for licenses and guidelines. They will be responsible for continuous improvement in the compliance space.
- Identify regulatory submission pathways and data requirements for new products and license submissions.
- Partner with marketing, production, packaging, cultivation, quality and validation functions, as well as external partners and regulatory bodies for smooth execution of new product introductions and international launches.
- Compile submissions and responses to ensure timely approvals.
- Provide interpretation and risk-impact analysis on regulations, guidelines, and policies, and deliver training as needed (Cannabis Act, GMP, and international regulations).
- Lead improvement activities within daily functions to maintain best practices for the provisions of the Cannabis Act and other regulations (Food and Drugs Act and Regulations).
- Continuously monitor regulatory trends from relevant regulatory bodies, and act on those to ensure continued compliance.
- Lead change controls for new products and processes.
- Assist with complaint and recall processes.
- Actively participate in internal and external audits and inspections.
- Assist with inspection responses and communication with regulatory authorities.
- Assist with all reporting requirements, including accurate record keeping, as outlined within the different regulations.
- Lead maintenance of life-cycle management of licenses.
Experience / Education
- 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 in consumer packaged goods and/or GMP.
- Ability to receive valid security clearance through Health Canada.
Skills & Abilities
- Excellent understanding of the various Cannabis Act and Regulations, Food and Drugs Act and Regulations, GPP, GMP.
- Experience in writing SOPs, change controls, NC/CAPA, change control documentation.
- Excellent understanding of international pharmacopoeia and ICH guidelines.
- Ability to work effectively in a team-based environment.
- Project management experience is an asset.
- Strong organizational, analytical and multi-tasking ability.
- Excellent written and verbal skills, capable of speaking professionally, clearly and concisely.
- Strong negotiation skills.
- Mostly desk work with a mixture of standing and walking and some light lifting.
- Generally fast-paced.
- Occasional exposure to strong odours resulting from testing and production procedures.
- On occasion, flexible hours of work may be required.
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.
Reference ID: 1060
Job Types: Full-time, Permanent
- Casual Dress
- Company Events
- Dental Care
- Employee Assistance Program
- Employee Stock Purchase Plan
- Extended Health Care
- Flexible Schedule
- Life Insurance
- On-site Parking
- Stock Options
- Vision Care
- Wellness Program
- 8 Hour Shift
- Day shift
- Monday to Friday
- Regulatory : 1 year (Required)