Regulatory Affairs and Quality Assurance Manager

3 weeks ago

Oakville, Canada XEDITON PHARMACEUTICALS INC Full time

**Company Description**:
Xediton is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario.

**REGULATORY AFFAIRS and QUALITY ASSURANCE MANAGER**

**Job Description & Key responsibilities**

The Regulatory Affairs & QA Manager is responsible for obtaining Drug, Medical Devices and Natural Health Product registrations with Health Canada. The incumbent is responsible in ensuring that all current products are in compliance with Health Canada. The Regulatory Affairs and QA Manager will support internal management.

**Specific responsibilities include**:

- Lead in the preparation, compilation, notification, amending and submissions of Drugs in the eCTD format to Health Canada to obtain market authorization
- Preparation and filing of Medical Devices and Natural Health Products to Health Canada
- Ability to Interpret clinical, scientific data and information
- Respond to requests from Health Canada - clarification for new submissions and compliance for existing products.
- Lead all Health Canada interactions
- Ensure all HC requirements and deadlines are met as it relates to annual drug notifications, Site License and DEL renewals.
- Lead regulatory inspections, lead internal and regulatory audits as required and execute the necessary corrective actions
- Maintain Standard Operating Procedures; Review of documentation for GMP purposes
- GMP responsibilities - including but not limited to leading investigations, reviewing and approving deviations and change controls
- Evaluate complaint reports for accuracy and working with the Pharmacovigilance team
- Maintain all documents - Batch Records, Master Manufacturing and Packaging Records
- Work with local and foreign site organizations on GMP matters to resolve issues as needed
- Provide technical and regulatory advice and support to the Business Development Team; Conduct risk assessment of Business Development projects and develop regulatory strategies.
- Ability to interpret and summarize clinical data
- Ensure that product labelling, package inserts and product monograph are accurate and compliant
- Finished Product Release
- Lead in the development of procedures and processes to ensure compliance with the Food and Drug Act and Regulations
- Work with external stakeholders and consultants

**Skills & Qualification**

**Educational Qualification**

Canadian University Science Degree or degree recognized as equivalent by a Canadian University or Accreditation body in Sciences with at least five years of previous Regulatory Affairs and QA experience. An additional RA Diploma is an asset

**Competencies**:

- Thorough understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Act and Regulations and a working knowledge of ICH requirements.
- Extensive Knowledge of Canadian GMPs
- Applies good document management practices.
- Hands-on working knowledge of eCTD structure and requirements
- Proven track record of compiling eCTD dossiers
- Modules 1 to 5
- Proficient computer skills, which would include Microsoft Office (Word, Excel, Outlook)
- Excellent communication skills(written and oral)
- Strong Project Management skills
- Superior organizational skills, with the ability to prioritize and handle multiple tasks and deadlines, works well under pressure and has a sense of urgency
- Self-starter who is able to work independently with mínimal supervision

**Salary**: $80,000 to $100,000 per annum
- **If this opportunity is of interest to you and are looking to working in a small company with growth opportunities, we would like to speak with you**_.

**Salary**: $80,000.00-$100,000.00 per year

**Benefits**:

- Dental care
- Disability insurance
- Extended health care
- Life insurance
- On-site parking
- Vision care

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Oakville, ON L6H 6X7: reliably commute or plan to relocate before starting work (required)

Application question(s):

- Do you currently require sponsorship to work in Canada?

**Education**:

- Bachelor's Degree (required)

**Experience**:

- eCTD Review and Compilation: 6 years (required)
- dealing with Health Canada requirements: 4 years (required)
- Pharmaceutical Regulatory Affairs: 6 years (required)
- Pharmaceutical QA/QC: 3 years (required)

Work Location: In person

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