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Job #03575

About our client Our client distributes pharmaceutical, OTC, nutraceutical and sports nutrition ingredients for pharmaceutical and nutraceutical product manufacturers and marketers. Position Location Regulatory Associate Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare regulatory submission documents in CTD format in adherence to applicable acts and regulations for submission to Health Canada 2) Manage activities associated with generating regulatory submissions, including identifying and sourcing submission content 3) Manage and plan submission timelines and projects 4) Publish submissions for regulatory group (notifiable changes, deficiencies and annual reports) 5) Facilitate regulatory approvals for DIN, NHP and OTCs through effective communication and negotiation with clients and government agencies 6) Evaluate new guideline documents to determine impact on processes 7) Manage and ensure maintenance of a positive and productive liaison with internal and external contacts, including regulatory agencies and clients 8) Maintain a strong customer service management approach with clients 9) Develop and implement process change under the direction of regulatory management 10) Identify issues that may delay product or project and recommend appropriate action. 11) Manage compliance related submissions and activities 12) Coordinate the development, writing and review of SOP for Quality Assurance to ensure full compliance with current GMP requirements 13) Provide ongoing QA services and performing GMP compliance activities. 14) Establish and follow procedures to ensure that products conform to specifications, stability and regulatory requirements Requirements 1) Minimum 2 years of related regulatory affairs experience within the generic pharmaceutical industry 2) Experience with healthcare products or natural health products submissions 3) Working knowledge of MS Office and Adobe Acrobat 4) Excellent communication skills, including medical/scientific writing experience 5) Good time management, problem solving, planning skills and attention to details 6) Ability to effectively prioritize, coordinate and complete multiple projects within established timeframes while maintaining a high level of accuracy