Regulatory Compliance Specialist

4 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


  • EHS Specialist

    3 weeks ago


    Brockville, Canada 3M Full time

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: 3M is seeking an EHS Specialist for its Personal Safety Division...

  • Mortgage Specialist

    2 weeks ago


    Brockville, Canada BMO Full time

    Application Deadline: 04/29/2024Address:1 Wall StreetCultivates, builds, and manages relationships with a third-party network of referral sources to build a pipeline of new mortgage business and increase BMO's share of the home financing market. Actively identifies sales opportunities and refers to BMO colleagues as appropriate. Develops and executes...

  • Mortgage Specialist

    3 weeks ago


    Brockville, Canada BMO Full time

    Application Deadline: 04/29/2024 Address: 1 Wall Street Job Family Group: Retail Banking Sales & Service Cultivates, builds, and manages relationships with a third-party network of referral sources to build a pipeline of new mortgage business and increase BMO’s share of the home financing market. Actively identifies sales opportunities and refers to BMO...

  • Mortgage Specialist

    3 weeks ago


    Brockville, Ontario, Canada BMO Full time

    Application Deadline:05/30/2024Address:1 Wall StreetJob Family Group:Retail Banking Sales & ServiceCultivates, builds, and manages relationships with a third-party network of referral sources to build a pipeline of new mortgage business and increase BMO's share of the home financing market. Actively identifies sales opportunities and refers to BMO colleagues...


  • Brockville, Canada Trillium Health Care Products Inc. Full time

    **PRIMARY RESPONSIBILITY** Responsible for the administration and management of all health safety and environmental programs. Including regulatory compliance, procedures, industrial hygiene exposure, WHMIS, safety compliance training, safety procedure development and review, safety promotion, and environmental compliance. **RESPONSIBILITIES** **Safety** -...


  • Brockville, Canada Trillium Health Care Products Inc. Full time

    **PRIMARY RESPONSIBILITY** Develop and maintain the Quality Control Instruments Qualification/Requalification/PM Program, providing onsite support for troubleshooting of instrumentation used in the QC Laboratory. **SPECIFIC DUTIES** - To ensure that all laboratory equipment/instruments used for testing and release of products are qualified in accordance...


  • Brockville, Ontario, Canada Brockville General Hospital Full time

    POSITION: Clinical Informatics SpecialistCOMPETITION: STATUS: Full-TimeDEPARTMENT: IMIT (Information Management, Information Technology) HOURS OF WORK: Monday-Friday Days (Subject to change based on operational needs)UNION ASSOCIATION: Non-UnionPOSITION SUMMARY:As a subject expert with a focus on the administrative and/or advanced clinical modules, the...

  • Vp of Finance

    4 weeks ago


    Brockville, Canada Trillium Health Care Products Inc. Full time

    **PRIMARY RESPONSIBILITY** The VP of Finance will oversee all financial matters for the organization by managing the financial and operational aspects of the company’s strategy, planning and budgeting. They will serve as the financial advisor to the CEO, senior leadership and Board of Directors team. **DETAILED DUTIES** - Oversee all facets of...

  • Payroll Coordinator

    3 weeks ago


    Brockville, Canada Groupe Leclerc Full time

    SUMMARY OF THE POSITION Reporting to the Payroll Supervisor, this position will support the existing payroll team. RESPONSIBILITIES Perform, with the team, the complete payroll cycle every 2 weeks (Canada, USA and UK).  Process and ensure compliance of all documents related to employee payroll; Carry out the usual verifications and ensure...

  • Payroll Clerk

    4 weeks ago


    Brockville, Canada Groupe Leclerc Full time

    SUMMARY OF THE POSITION Reporting to the Payroll Supervisor, this new position will provide support to the existing payroll team. This position will allow the candidate to learn a great deal about payroll processing and does not require extensive experience.  RESPONSIBILITIES Assist the Payroll Coordinators with the full bi-weekly payroll cycle...


  • Brockville, Canada Trillium Health Care Products Inc. Full time

    **Basic Function** To ensure that all products manufactured and/or packaged at Trillium are safe, pure, and effective, and that they comply with established quality standards and specifications according to current Good Manufacturing Practices guidelines. **Responsibilities** - Review manufacturing and packaging batch records to ensure accuracy and...


  • Brockville, Canada Trillium Health Care Products Inc. Full time

    **Basic Function** To ensure that all products manufactured and/or packaged at Trillium are safe, pure, and effective, and that they comply with established quality standards and specifications according to current Good Manufacturing Practices guidelines. **Responsibilities** - Review manufacturing and packaging batch records to ensure accuracy and...

  • Plant Manager

    3 days ago


    Brockville, Canada Lafarge Canada Full time

    Whatever you do, you'll make a difference at Lafarge Canada. Because we know that your passion and curiosity are the natural resources the world needs. Thanks to our teams' energy, commitment and ideas, we are reinventing how the world builds to make Canada greener and smarter for all. Plant Manager **Requisition ID**:6222**Location**:Brockville, ON, CA,...

  • Material Handler

    5 days ago


    Brockville, Canada Groupe Leclerc Full time

    Leclerc is a family business with 117 years of experience, tradition and know-how passed down from people with heart. Thanks to our 1,400 employees in nine plants in Canada and the United States, we are constantly innovating to exceed the expectations of both small and large appetites. *** Reporting to the Warehouse Supervisor/Manager, the Material Handler...

  • Plant Manager

    4 days ago


    Brockville, Canada Lafarge Canada Full time

    Whatever you do, you'll make a difference at Lafarge Canada. Because we know that your passion and curiosity are the natural resources the world needs. Thanks to our teams' energy, commitment and ideas, we are reinventing how the world builds to make Canada greener and smarter for all.Plant ManagerRequisition ID: 6222Location:Brockville, ON, CA, K6V 5V2...

  • Plant Manager

    4 days ago


    Brockville, Canada Lafarge Canada Full time

    Whatever you do, you'll make a difference at Lafarge Canada. Because we know that your passion and curiosity are the natural resources the world needs. Thanks to our teams' energy, commitment and ideas, we are reinventing how the world builds to make Canada greener and smarter for all.Plant ManagerRequisition ID: 6222Location:Brockville, ON, CA, K6V 5V2...

  • Plant Manager

    4 days ago


    Brockville, Canada Lafarge Canada Full time

    Whatever you do, you'll make a difference at Lafarge Canada. Because we know that your passion and curiosity are the natural resources the world needs. Thanks to our teams' energy, commitment and ideas, we are reinventing how the world builds to make Canada greener and smarter for all.Plant ManagerRequisition ID: 6222Location:Brockville, ON, CA, K6V 5V2...