Regulatory Compliance Specialist

2 weeks ago

Brockville, Canada Trillium Health Care Products Full time

**Basic Function**

To ensure that regulatory requirements are met and provide regulatory guidance for Trillium Health Care Products Inc.

**Responsibilities**
- Review Label Text for Trillium private label products and verify text meets regulatory requirements
- Update/prepare label text as specified in the DIN submission for Trillium private label products
- DIN changes and NHP submissions for Trillium products
- Prepare and submit license renewals, amendments and notice of changes.
- Prepare U.S. drug listings for submission to the FDA
- Verify customer information and prepare FDA registrations for U.S. agent
- Review GMP and Regulatory guidance documents for changes and ensure compliance
- Prepare precursor import/export permits and submit annual precursor reports.
- Prepare and submit annual drug notification
- Prepare and submit Pharmacovigilance Reports
- Prepare Customs letters as required
- Update DIN, NHP and US Product List as required based on change management documentation
- Respond to Product Information inquiries as required
- Follow-up with customs inquiries
- Audit precursor storage and documentation practices
- Maintain site master file
- Assist with customer and regulatory audits
- Perform internal audits
- Complete CAPA effectiveness checks
- Prepares APRs as required
- Requalify vendors as needed
- Requalify vendors as needed
- Backup the QS Compliance Supervisor as required
- Other duties as required

**Qualifications**
- 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
- Night shift

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Regulatory Affairs certificate or CAPRA membership: 5 years (preferred)
- pharmaceutical regulatory: 5 years (preferred)

Work Location: One location

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