Manager - Regulatory Affairs
- North York, ON | Full-time, Permanent
Reporting directly to the VP Quality & Regulatory Affairs, the Manager, Regulatory Affairs is responsible for strategy and life-cycle management of all (cannabis) licenses and certifications of Aleafia Health. He/she provides interpretation and risk-impact analysis on updated regulatory guidelines/policies/regulations and delivers training/communication as needed. The incumbent leads the Regulatory Affairs team. He/she liaises with internal and external partners and regulatory bodies for licenses, complaints and inspections and works with a high level of autonomy. Enabling continuous improvement in compliance and regulatory space is a key element for the role.
Travel: Due to the multi-site nature of this role, this incumbent will travel to Paris, ON.
- Provides leadership of Regulatory Affairs team assuring that processes are executed effectively and compliant and that resources are planned and utilized effectively.
- Train and coach staff to the highest standards.
- Identify regulatory submission pathways and data requirements for new license and amendment/change 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 (GMPs and Cannabis act).
- Enable and lead improvement activities in the Regulatory Affairs and Compliance space.
- Continuously monitor regulatory trends from relevant regulatory bodies and act on those to ensure continued compliance.
- Oversee complaint and recall processes
- Lead inspection responses and communication with authorities
- Actively participate in internal and external audits and inspections
- Oversee with all reporting requirements, including accurate record keeping, as outlined within the different regulations.
Experience / Education
- Degree in a relevant field (i.e. pharmaceutical, biotechnology, science, chemistry, microbiology and biology).
- 5+ years relevant Quality and/or regulatory/compliance experience in a regulated environment (preferably GMP/GPP compliant).
Skills & Abilities
- Ability to receive valid security clearance through Health Canada.
- Ability to act as site Responsible Person under Cannabis Act.
Excellent understanding of the various Cannabis Regulations and GMPs.
- Ability to work effectively in a team-based environment.
- Project management experience is an asset.
- Excellent analytical and problem-solving skills.
- Outstanding communication skills, written and verbal.
- Good understanding with international pharmacopoeia and ICH guidelines.
- Strong negotiation 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.
- Extended health care
- Vision care
- Vacation & paid time off
- Disability insurance
- Stock options
- Employee assistance programs
- Dental care
- Life insurance
- Casual dress