Job Description

/ Roles and Responsibilities for Job Title:1) Maintain an excellent knowledge of clinical trials/clinical research and a thorough understanding of industry regulatory requirements2) Stay current on regulatory updates and issue regular communications bulletins within the organization3) Prepare, review and submit applications to Regulatory Agencies in Canada (Clinical Trial Applications, Investigation Testing Authorization, Medical Device License Application) and the US (Investigational New Drug Applications, Pre-IND Meeting Requests and Briefing Packages)4) Communication with the regulatory agencies (e.g., Health Canada, EMEA, FDA) and/or via the sponsor in response to regulatory issues raised in regulatory documents such as clarifaxes or deficiency letters5) Conduct and support all other Regulatory submissions, including but not limited to, SAEs, End of Study Notifications, Amendments, responses to clarifaxes and/or other submissions queries/questions/observations, etc.6) Submit applications for Controlled Substances Licenses, Changes Affecting Personnel in Charge, and Cannabis Research License, renewals, and/or amendments (as applicable)7) Filing of controlled substances import permits, exemption applications and inventory reports to regulatory authorities8) Completion of Bioequivalence Summary Tables and Comprehensive Summary - Bioequivalence Report for Submission to regulatory authorities9) Creation and maintenance of regulatory resources for the company with respect to the following regulatory bodies: Health Canada, FDA, EMEA, MHRA; others as needed10) Register appropriate clinical trials with ClinicalTrials.gov as per FDAAA 801 requirements11) Provide regulatory advice and input as required12) Work in a safe manner that does not endanger yourself or co-workers13) Delegate tasks as appropriate to members within the regulatory team in order to meet timelines efficiently14) Preparation of other submissions not identified above, if/as requested (i.e. Ethics, etc.)15) Execute other duties as required by RA ManagementAny Additional responsibility given by Head of the Department / ManagementQualifications:\xc2\xb7 Bachelor of Science (B.Sc.) degree in life sciences\xc2\xb7 Post-graduate Regulatory Affairs certification an asset\xc2\xb7 Minimum 1-3 years regulatory affairs experience within the pharmaceutical/CRO industry\xc2\xb7 Current with regulatory requirements pertaining to clinical research (Health Canada, FDA), ICH, GCP, GDP, GMP, GLP, Code of Federal Regulations (21CFR)\xc2\xb7 Experience associated with the conduct of activities pertaining to registrations and submissions with Health Canada, FDA (IRBs an asset)\xc2\xb7 Possess a highly developed regulatory mindset as it pertains to BE and phase I-IV clinical trials\xc2\xb7 Strong analytical and problem solving skills\xc2\xb7 Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively\xc2\xb7 Excellent interpersonal skills\xc2\xb7 Strong written and verbal communication skillsJob Type: Full-timeSalary: $45,000.00-$80,000.00 per yearBenefits:

• On-site parking

Flexible Language Requirement:

• French not required

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Mississauga, ON L4W 1A4: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor's Degree (preferred)

Work Location: In person