Located in Barrie, Ontario, MediPharm Labs offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry, named Start-Up of the Year at the most recent Canadian Cannabis Awards. Our growing team of scientists, technicians, engineers and business professionals delivers quality and innovation through research, discipline, and forward thinking.The Regulatory Affairs Specialist will be responsible for coordinating assignments related to regulatory and compliance affairs within the company; maintaining and expanding the scope of existing licences.This position is based in Barrie, Ontario regularly working 40 hours per week. Responsibilities:Submit regulatory filings for monthly inventory reports to Health Canada, Canadian Revenue Agency and respond to government agencies' inquiriesResponsible for the selection of packaging and labelling materials for various customersResponsible for timely submission of regulatory artwork to support medical, adult-use and international markets - issue GS1 numbers for new product SKUsPrepare regulatory submissions including but not limited to Quality Overall Summary, Active Substance Master Files.Generate label template, review packaging and labeling elements pertaining to Health Canada and Australian Goods Administration regulations.Work closely with both internal stakeholders (Marketing/Supply Chain/Regulatory Affairs) and external stakeholders (i.e. artwork vendors, suppliers) to identify and resolve discrepancies and/or issuesParticipate in cross-functional teams and advise personnel of relevant information and communications regarding regulatory filings and licensingAssist the Regulatory Affairs Manager during external audits as requiredSupport 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 policiesSupport internal compliance initiatives related to the legalization of cannabis in Oct 2018Skills/ Qualifications: Regulatory Affairs experience in the healthcare and/or in the cannabis industry. Direct interaction with Health Canada and other government regulatory bodies for regulatory inspections, submissions and licenses.Experience in the compilation or submission of various regulatory filings an asset.Excellent verbal and written communication skillsHigh degree of integrityExcellent organizational skills able to work effectively in a fast paced, operational environmentSc. with minimum of 2 years of Regulatory Affairs experience in healthcare industry (e.g. medial cannabis, natural health products, pharmaceutical and/or medical device) required

Regulatory Affairs Specialist

Located in Barrie, Ontario, MediPharm Labs offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry, named Start-Up of the Year at the most recent Canadian Cannabis Awards. Our growing team of scientists, technicians, engineers and business professionals delivers quality and innovation through research, discipline, and forward thinking.

The Regulatory Affairs Specialist will be responsible for coordinating assignments related to regulatory and compliance affairs within the company; maintaining and expanding the scope of existing licences.

This position is based in Barrie, Ontario regularly working 40 hours per week. 

Responsibilities:

  • Submit regulatory filings for monthly inventory reports to Health Canada, Canadian Revenue Agency and respond to government agencies' inquiries
  • Responsible for the selection of packaging and labelling materials for various customers
  • Responsible for timely submission of regulatory artwork to support medical, adult-use and international markets - issue GS1 numbers for new product SKUs
  • Prepare regulatory submissions including but not limited to Quality Overall Summary, Active Substance Master Files.
  • Generate label template, review packaging and labeling elements pertaining to Health Canada and Australian Goods Administration regulations.
  • Work closely with both internal stakeholders (Marketing/Supply Chain/Regulatory Affairs) and external stakeholders (i.e. artwork vendors, suppliers) to identify and resolve discrepancies and/or issues
  • Participate in cross-functional teams and advise personnel of relevant information and communications regarding regulatory filings and licensing
  • Assist the Regulatory Affairs Manager during external audits as required
  • 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
  • Support internal compliance initiatives related to the legalization of cannabis in Oct 2018

Skills/ Qualifications: 

  • Regulatory Affairs experience in the healthcare and/or in the cannabis industry. Direct interaction with Health Canada and other government regulatory bodies for regulatory inspections, submissions and licenses.
  • Experience in the compilation or submission of various regulatory filings an asset.
  • Excellent verbal and written communication skills
  • High degree of integrity
  • Excellent organizational skills able to work effectively in a fast paced, operational environment
  • Sc. with minimum of 2 years of Regulatory Affairs experience in healthcare industry (e.g. medial cannabis, natural health products, pharmaceutical and/or medical device) required

To apply online, please click on the appropriate link below.