Regulatory Compliance Specialist

Regulatory Compliance Specialist – Quality Services

PRIMARY RESPONSIBILITY

To provide regulatory guidance and ensure compliance with regulatory and GMP requirements at Trillium Health Care Products Inc.

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 needed

SECONDARY 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 assigned

EDUCATION/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 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