Position:                                Regulatory Engagement Coordinator

Report to:                              Licensing Regulatory Engagement Manager

 

Your daily responsibilities will include:

 

  • Serve as an integral member of the Licensing Regulatory Engagement team, interact cross-functionally to ensure business objectives are aligned, and ensure that the organization meets its quality and business goals;
  • Collaborate with other departments (e.g., Quality Assurance, Operations, Legal, Marketing and Human Resources) to direct licensing and compliance issues appropriately regarding investigation, resolution, vulnerability and risk
  • Deliver consistency and additional oversight in municipal, employment and general compliance, and documentation across the organization; Coordinate the preparation and completion of licensing and regulatory compliance documents and ensure the satisfaction of local, provincial, and federal government requirements at an organizational level;
  • Contribute to leading business innovations through licensing projects and researching regulations that align with company objectives including the integration of multiple programs and regulatory compliance requirements;
  • Assist in developing and reviewing policies and procedures for the general operation of the Regulatory Compliance and Quality Assurance processes to prevent illegal, unethical, or improper conduct; Aid in tracking deviations, preparation of training SOPs, and in all other relevant compliance activities;
  • Work extensively with highly confidential information, including the generation and maintenance of licenses, applications, legal and regulatory documentation. Update documents as required to address changes to laws, regulations, or company rules; Obtain proper executive review and authorization prior to release;
  • Participate in audits and ensure written policies and documentation meet company needs and regulatory requirements prior to inspection;
  • Support in collection and management of auditable records and files to maintain the Information Management System for an effective organization-wide compliance and cross-functional record keeping system (policy and operational amendments, application forms, communication logs, regulatory reports, and other require regulatory documents);
  • Support Senior Level Management in coordinating licensing compliance review activities; and
  • Other tasks as assigned by management.

 

Qualifications:

 

Knowledge:

 

  • Strong understanding and experience in working with Health Canada, CRA, CFIA and other regulatory agencies;
  • Sound comprehension of ACMPR & NCR requirements strongly preferred;
  • Knowledgeable in CDSA, FDA, and other Canadian Acts & Regulations;

 

Skills:

 

  • Proficiency with MS Office and ERP software systems;
  • Strong time management and organization skills to keep priorities in focus;
  • Excellent communication, documentation, research and presentation skills;

 

Abilities:

 

  • Ability to interface with cross-functional and high-performance teams focused on accountability and meeting and exceeding expectations;
  • Ability to research & analyze regulations for strategic development of multiple projects;
  • Ability to forecast potential obstacles and assess risks; and
  • Ability to write cohesive and comprehensive reports for communication with multiple stakeholders;

 

Other Qualifications and Experience:

 

  • Bachelor’s Degree (i.e. Chemistry, Biochemistry, Pharmaceutical, Political Science);
  • 2-3 years of Licensing and/or Regulatory experience;
  • 2-3 years’ experience in a highly regulated environment (i.e. pharmaceutical, food or natural health industries); and
  • Demonstrated experience in licensing applications, regulatory research and compliance.

 

Agrima Botanicals values a diverse workforce and encourages all interested applicants to apply.  Those candidates whose skills and qualifications fit the role requirements will be further considered and contacted.  Candidates chosen for employment will be required to undergo background and reference checks.

 

Thank you for your interest in employment opportunities with Agrima Botanicals!