Regulatory Compliance Specialist \xe2\x80\x93 Quality Services PRIMARY RESPONSIBILITY To provide regulatory guidance and ensure compliance with regulatory and GMP requirements at Trillium Health Care Products Inc. PRIMARY DUTIES \xc2\xb7 Review GMP and Regulatory Policies and Guidance Documents for changes and ensure compliance \xc2\xb7 Prepare and submit all license renewals, amendments and notice of changes to appropriate regulatory authorities and obtain new licenses if required \xc2\xb7 Prepare US Drug Listings for submission to the FDA through US agent \xc2\xb7 Verify customer information and review FDA Registration paperwork for US agent \xc2\xb7 On an Annual basis provide any updated labels to US agent to ensure US Drug Listings are up to date \xc2\xb7 Ensure all fees to FDA are paid on time \xc2\xb7 Submit Annual Drug reporting paperwork to FDA \xc2\xb7 Prepare and handle all paperwork related to Precursor Import/Export permits and submit Annual Precursor reports \xc2\xb7 Ensure monthly excise paperwork for Alcohol is completed on time \xc2\xb7 Obtain Alcohol formulation numbers from CRA as required \xc2\xb7 Prepare and submit annual drug notification \xc2\xb7 Prepare Pharmacovigilance Reports and submit to regulatory authority upon request \xc2\xb7 Update Product listings as required based on change management documentation \xc2\xb7 Respond to Product Information inquiries as required \xc2\xb7 Prepare customs letters and help with customs inquiries \xc2\xb7 Maintain site master file \xc2\xb7 Conduct annual mock recall \xc2\xb7 Review labels for acceptability based on regulations and/or internal Trillium requirements for use. \xc2\xb7 Be able to prepare submissions for Trillium owned products and submit to regulatory authorities if needed SECONDARY DUTIES \xc2\xb7 Assist with customer and regulatory audits \xc2\xb7 Perform internal audits \xc2\xb7 Complete CAPA effectiveness checks \xc2\xb7 Prepare APRs as required \xc2\xb7 Requalify/Qualify vendors as needed \xc2\xb7 Backup the QS Compliance Supervisor as required \xc2\xb7 Other duties as assigned EDUCATION/EXPERIENCE \xc2\xb7 Minimum 5 years of pharmaceutical experience in a regulatory position \xc2\xb7 University degree in a related science \xc2\xb7 Regulatory Affairs certificate or CAPRA membership an asset \xc2\xb7 Demonstrated problem solving skills Job Types: Full-time, Permanent Salary: From $65,000.00 per year Benefits:

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

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Application question(s):

• Do you have a Regulatory Affairs Certificate?
• Do you have a CAPRA membership?

Education:

• Bachelor\'s Degree (required)

Experience:

• pharmaceutical regulatory: 5 years (required)

Work Location: One location