Regulatory Affairs and Quality Assurance Manager - Oakville, Canada - Xediton Pharmaceuticals

Xediton Pharmaceuticals

Verified Company

Oakville, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Vacancy Overview

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.

Company Description

Xediton is a privatelyheld pharmaceutical company with a focus on meeting the needs of patients, physicians, and partners. We are located in Oakville, Ontario.
Department:

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Regulatory Affairs & Quality Assurance

Project Location(s):

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Oakville

Education:

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Canadian University Science Degree

Salary:

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$80,000 to $100,000 per annum

Job Type:

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Full Time

Skills & Experience

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.
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

Responsibilities

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

Salary
$80,000 to $100,000 per annum