Regulatory Compliance Specialist

6 days ago

Brockville, Canada Trillium Health Care Products Full time

**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

**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

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