Regulatory Affairs Associate
Reference ID: CanMar137JOB
Well trained in compliance procedures, policies, standards and obligations including Canadian privacy laws and import/export regulations;
The Regulatory Affairs Associate functions as an outward facing administrative body to the Quality Assurance team, Executives and other Senior level management, by cross-functionally coordinating the business and compliance activities between departments and stakeholders. This role supplements compliance as it pertains to business development initiatives, partner suppliers, importing/exporting, licensing, and other auditable record keeping, particularly deviation reporting. The primary purpose of the Coordinator role is to ensure compliance and operational transparency of communication and documentation as it relates to ACMPR and Health Canada regulations.
Strong and current knowledge of ACMPR, HACCP, Food Safety, regulatory and environmental guidelines;
Excellent grasp on reporting procedures and record keeping;
Strong computer literacy to include understanding of Microsoft Office Suite, Google Suite, ADP, and Acrobat;
Demonstrated knowledge of quality assurance procedures and standards;
Collaborate with other departments (e.g., Quality Assurance, Operations, Legal, and Human Resources) to direct compliance issues appropriately regarding investigation, resolution, vulnerability and risk; Serve as an integral member of the Quality Assurance team, interact cross-functionally to ensure business objectives are aligned, and ensure that the organization meets its quality and business goals
Deliver consistency and additional oversight in municipal, employment and general compliance and documentation across the organization; coordinate the preparation and completion of regulatory and compliance documents and ensuring the satisfaction of provincial and local government requirements at an organizational level;
Track deviations and compile deviation reports; communicate findings, correction strategies, and all other relevant information to the QAP and the Chief Quality and Compliance Officer;
Assist in development, initiation, maintenance, and revision of policies and procedures for the general operation of the Quality Assurance and Regulatory Compliance processes to prevent illegal, unethical, or improper conduct;
Maintain Information Management System and access controls for an effective organization-wide compliance and cross-functional record keeping system;
Assist in collection and management of an auditable records and files from Health Canada and GMP Audits etc.
Update documents as needed to address changes to laws, regulations, or company rules and obtains proper executive review and authorization prior to release;
Support Senior Level Management in coordinating internal compliance review activities;
Administrative participation in various business transactions (i.e. purchase and sale of plant materials, procurement of supplies, tools and other internal/external resources);
Help lead the innovation and continuous improvement of internal control frameworks, including the integration of multiple programs and compliance requirements;
Work extensively with highly confidential information, reviewing of permits for import and export; and
Other tasks as assigned by management.
Bachelor's Degree in Biological Science (i.e. Microbiology, Biotechnology, Chemistry, Biochemistry, Pharmaceutical);2-3 years of Quality Assurance and Control experience, preferably in a strongly regulated environment;
2-5 years' experience in a compliance or administrative setting, preferably in a strongly regulated environment;
Experience in working and understanding hazard critical control analysis. Certification in hazard analysis and critical control points (HACCP) considered an asset;
Experience with inspecting production resources, packaging material and medicinal material, and issuing inspection reports;
High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction;
Must be able to pass a criminal record check.
Security Clearance may be requested for this position.
If you are interested in this opportunity, please apply with an updated resume in MS Word Format.
Due to the volume of resumes we receive, only those applicants whose skill set match our requirements will be contacted.
All applicants must have legal authorization to work in Canada for an unlimited period of time.
Posted: November 13, 2018
Closes: January 12, 2019