Regulatory Affairs and Quality Assurance Manager - Oakville, Canada - XEDITON PHARMACEUTICALS INC
Description
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.
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.
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.
- Handson working knowledge of eCTD structure and requirements
- Proven track record of compiling eCTD dossiers
- Modules 1 to
- 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
- Selfstarter who is able to work independently with mínimal supervision
Salary:
$80,000 to $100,000 per annum
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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
- Onsite 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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