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Miles
Km80.5

Animal Health Regulatory Affairs, Aqua

Prince Edward Island BioAlliance

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Location: Charlottetown, CANADA - PRINCE EDWARD ISLAND Posted Date: 4/24/2013 Position Type: Full time Job Code: Regulatory Affairs, Aqua Required Education: Bachelors Degree Areas of Expertise Desired: Regulatory Affairs

Description

Job Purpose
To achieve and maintain product approvals and manage regulatory events related to NAH (Novartis Animal
Health) business, by:
• Supporting product applications and registrations for all assigned countries/products
• Liaising with colleagues to meet Canadian and other local regulatory requirements
• Communicating regulatory requirements to support regulatory compliance efforts

Major Accountabilities
• Define and implement Canadian and International regulatory strategies for assigned Novartis Animal Health Canada Inc. product applications and post-approval changes.
• Provide required documentation to support product applications and approvals for all assigned ex- Canada countries/products, including registration of new products and maintenance of existing products, through close collaboration with technical experts and Country Business Unit Regulatory Affairs Managers.
• Establish and maintain general understanding and knowledge of regulatory requirements for all countries supported.
• Ensure regulatory compliance in evaluating change requests and coordinate submission of post-approval changes for all assigned countries/ products.
• Collate and manage regulatory dossiers for assigned products, including written responses to reviewer comments, product labels and inserts text, and associated written materials.
• Advise Technical Operations, Research &Development, Quality Assurance and Quality Control on document content, compliance issues, and format and reporting obligations to meet regulatory requirements.
• Obtain and maintain import permits, export permits, certificates and Establishment and Product Licenses.
• Manage working relationships with the government authorities related to product responsibilities and
submissions.

Job Dimensions
Number of associates: n/a
Financial responsibility:
(Budget, Cost, Sales, etc.)
$600,000
Impact on the organization: New product approvals and product registration maintenance worldwide
are critical to worldwide business success.

Requirements

Background
Education :
• Bachelors or equivalent in a scientific or regulatory discipline preferred.
Suitable candidates without a scientific degree but with extensive
regulatory affairs experience may be considered.
• Fluency in spoken/written English.
Experience:
New product approvals and product registration maintenance worldwide are
critical to worldwide business success.
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