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Regulatory Affairs Associate - Windsor, Canada - Jamieson Wellness Inc.
Description
Overall ResponsibilitiesReporting to the Supervisor, lnternational Regulatory Affairs the lnternational Regulatory Affairs Associate will prepare and maintain regulatory submissions to various international government regulatory bodies.
The position requires regular interaction with the international sales and marketing department, all S&T areas, as well as international customers, requiring a dynamic individual able to properly interpret and communicate regulatory requirements to meet with needs of the business.
Specific Key Responsibilities & DutiesAssembly and tracking of registration dossiers in a timely and accurate mannerRequesting and preparing raw material (RM) and finished good (FG) samples to be shipped for product registrations in a timely and accurate mannerAssembly and tracking of export documentation and license renewals in a timely and accurate mannerWorking with QC/QA/R&D in the development of new raw material (RM) and finished good (FG) specs to bring in to compliance with regulationsWorking with account managers to help answer customer questions, concerns and/or provide further documentation if neededReviewing ingredients/formulas for alternate markets based on regulatory requirementsReviewing technical documentation generated, from both internal and external sources, for international registrations r Reviewing international labels for complianceFollows Health & Safety Policies/SOPs including but not limited to the Safety Responsibilities ProcedureWill comply with Good Manufacturing Practices in all GMP sensitive areas of Jamieson Laboratories Ltd.
facilitiesldentifying creative solutions for overcoming regulatory challengesIdentifying new opportunities for lnternational sales within the regulatory environmentManage and track long-term goals the contribute to the broader objectives of the Regulatory Affairs department and the organization.
Other duties and projects as deemed necessary
Knowledge, Skills & Abilities RequirementsBachelor degree in Science/Biological SciencesRegulatory experience an assetAbility to understand and interpret technical documentsAbility to use scientific judgement with minimal supervisionAbility to multitask and complete work in a timely mannerExcellent written and oral communication skillsStrong organizational and administrative skillsProficient with computers.