Junior Regulatory Affairs Specialist AgMedica Chatham-Kent, ON Remote

The Junior Regulatory Affairs Specialist, under the guidance of the Manager of Regulatory Affairs, and as a key support to the Regulatory and Quality Assurance Management team, will be responsible for informing and advising on regulatory changes and compliance. As a subject matter expert on the Cannabis ActCannabis Regulations, and all other pertinent legislation, the Junior Regulatory Affairs Specialist will assist in developing AgMedica’s regulatory structure, helping to ensure its policies, procedures, quality management system and reporting practices surpass all regulatory requirements.

Major Duties:

· Function as Subject Matter Expert on all regulatory information, providing advice and feedback on research findings, changes to regulations, and provide recommendations;

· Support internal regulatory compliance by working with interdepartmental teams to establish and/or improve processes by reviewing and/or providing input regarding existing Standard Operating Procedures (SOPs), controlled forms and policies

· Participate in regular internal compliance audits and Health Canada inspections to enable standards for conformance;

· Serve as a key individual in helping the Manager of Regulatory Affairs to manage and prepare submissions/applications to Health Canada along with any amendments, change notifications, recall and adverse reaction reporting, non-conformance reporting, security occurrences, and all other correspondence as required;

· Master several tasks and timelines at once while being organized and having attention to detail;

· Proactively trouble shoot, problem solve and complete projects independently with appropriate direction and feedback from the Manager of Regulatory Affairs;

· Work in partnership with all teams – advising on regulations and compliance goals;

· Perform other tasks, such as excise stamp reporting, OSP changes and internal audit reporting as directed by the Manager of Regulatory Affairs and Senior Management.

Other Duties:

· Work with the Manager of Regulatory Affairs, senior management, executive members, and a diverse cross-functional team.

· Employ professional and clear communication practices to maintain a positive and progressive atmosphere across Operating, Administrative, Quality Assurance and Sales and Marketing departments;

· Deliver excellent oral and written communication skills;

· Comply with all HR policies including confidentiality and non-disclosure.

· Carry out other duties as assigned by members of the Senior Management Team.

Requirements:

· Always adhere to AgMedica Standard Operating Procedures (SOP) to ensure quality and efficacy in all activities;

· Daily, follow all federal, provincial, and municipal regulations for safety during all grow and cultivation operations;

· Familiar with and follow the Cannabis Act and its regulations; follow cGMP/EU-GMP and GACP standards.

Qualifications:

· Post Secondary education – paralegal or law clerk experience/education considered an asset

· 1-2 years experience working within a regulatory environment.

· Keen research skills.

· Detail oriented

· Experience in and knowledge of current Good Manufacturing Practices (cGMP), EU-GMP, GACP considered an asset.

· Strong IT knowledge and skills, including superior use of Microsoft Office applications (Outlook, Excel, Word, PowerPoint).

· Demonstrate necessary comprehension of the English language.

Job Types: Full-time, Permanent

Salary: $45,000.00 per year

Benefits:

  • Casual dress
  • Dental care
  • Employee assistance program
  • Extended health care
  • Flexible schedule
  • On-site parking
  • Vision care
  • Work from home

Schedule:

  • 8 hour shift

Education:

  • Secondary School (preferred)

Work remotely:

  • Yes

COVID-19 precaution(s):

  • Remote interview process

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