Job Description

PRIMARY RESPONSIBILITYTo provide regulatory guidance and ensure compliance with regulatory and GMP requirements.PRIMARY DUTIES Review GMP and Regulatory Policies and Guidance Documents for changes and ensure compliance Prepare and submit all license renewals, amendments and notice of changes to appropriate regulatory authorities and obtain new licenses if required Prepare US Drug Listings for submission to the FDA through US agent Verify customer information and review FDA Registration paperwork for US agent On an Annual basis provide any updated labels to US agent to ensure US Drug Listings are up to date Ensure all fees to FDA are paid on time Submit Annual Drug reporting paperwork to FDA Prepare and handle all paperwork related to Precursor Import/Export permits and submit Annual Precursor reports Ensure monthly excise paperwork for Alcohol is completed on time Obtain Alcohol formulation numbers from CRA as required Prepare and submit annual drug notification Prepare Pharmacovigilance Reports and submit to regulatory authority upon request Update Product listings as required based on change management documentation Respond to Product Information inquiries as required Prepare customs letters and help with customs inquiries Maintain site master file Conduct annual mock recall Review labels for acceptability based on regulations and/or internal Trillium requirements for use. Be able to prepare submissions for Trillium owned products and submit to regulatory authorities if neededSECONDARY DUTIES Assist with customer and regulatory audits Perform internal audits Complete CAPA effectiveness checks Prepare APRs as required Requalify/Qualify vendors as needed Backup the QS Compliance Supervisor as required Other duties as assignedEDUCATION/EXPERIENCE Minimum 5 years of pharmaceutical experience in a regulatory position University degree in a related science Regulatory Affairs certificate or CAPRA membership an asset Demonstrated problem solving skillsJob Types: Full-time, PermanentSalary: From $65,000.00 per yearBenefits:

• Company pension
• Dental care
• Employee assistance program
• Extended health care
• Life insurance
• Profit sharing

Schedule:

• 12 hour shift
• 8 hour shift
• Monday to Friday
• Weekend availability

Ability to commute/relocate:

• Brockville, ON: reliably commute or plan to relocate before starting work (required)

Application question(s):

• Are you legally able to work in Canada?
• Have you ever been convicted inwhich you have not received a pardon for?

Experience:

• related Pharmaceutical: 5 years (required)

Licence/Certification:

• Regulatory Affairs certificate or CAPRA membership? (preferred)