Regulatory Affairs Associate - Fort Erie, Canada - CannaCure Corporation
Description
Title:
Regulatory Affairs Analyst
Reports To:
Regulatory Affairs and Compliance Manager
Position Goal:
Regulatory Affairs Analyst will help enforcement strategies to ensure regulation compliance. To make sure that necessary documentation and reporting is completed and submitted. This role will form a conduit between regulatory affairs manager and the divisions within Operations.
Ensure more regular on-site regulatory presence at the facility and keeping each department informed of applicable regulations and what needs to be done to ensure the regulations are fully and properly followed.
This position will oversee the regulatory responsibilities surrounding the Research licence at Cannacure (testing, reporting, documentation, sampling, etc.). This position will be responsible for performing regular audits both internally and third-party audits.Position Summary:
Data and technology focused role aiding both the regulatory affairs team as well as the quality assurance team.
The Regulatory Affairs Analyst aids with adherence to all NNCPs relating to current Health Canada regulations and other applicable regulatory programs.
The Regulatory Affairs Analyst will be responsible for Data organization, input and interpretation with Government based computer programs for reporting requirements.
Help with raw material sampling, bulk transfer product sampling and monitoring of production documentation.Core Competencies:
- Effective oral communication
- Effective written communication
- Attention to detail
- Ethical
- Problem solving
- Results oriented
- Analytical
- Confidentiality
- Strategic thinking
- Compliance
- Quick Learner
- Collaborative
- Work independently
- Multitasking
- Integrity
- Time Management
Job Duties:
- Organize and input required compliance data into the Federal Government electronic database system (CTLS).
- Support the creation of both team and crossfunctional controlled documentation and technical resources. May involve being responsible for employee training as it pertains to the regulations.
- Assist in the documentation of regulatory risks, regulatory master submission sheets, and assist in the filing of consumer incident reports, recalls, and other compliance reports or logs.
- Work with commercial team regarding Provincial regulations and registrations to implement compliance.
- Responsible for activities surrounding the Research licence at Cannacure (including, but not limited to) sensory testing, reporting, documentation control, sampling, etc.
- Responsible for scheduling and performing routine audits: both internal as well as thirdparty audits.
Qualifications:
- 1+ years' experience with cannabis compliance
- Working knowledge of the Cannabis Act and Cannabis Regulations would be beneficial
- Proficiency in MS Office (Word, Excel, and PowerPoint), Adobe Pro
- Ability to draft and review controlled documents
- Working knowledge of GMP compliance, SOPs, PCPs, and regulatory audits
Working Conditions:
- Available for work travel as needed
- Available for onsite work in Fort Erie, ON
Application Process:
Job Types:
Full-time, Permanent
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Fort Erie, ON L2A 2S9: reliably commute or plan to relocate before starting work (required)
Work Location:
In person
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