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    Pharmaceutical Quality Associate - Windsor, ON, Canada - Jamieson Wellness Inc.

    Jamieson Wellness Inc.
    Jamieson Wellness Inc. Windsor, ON, Canada

    1 week ago

    Default job background
    Accounting / Finance
    Description

    Overall Responsibilities Reporting 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 & Duties
    Assembly and tracking of registration dossiers in a timely and accurate manner
    Requesting and preparing raw material (RM) and finished good (FG) samples to be shipped for product registrations in a timely and accurate manner
    Assembly and tracking of export documentation and license renewals in a timely and accurate manner
    Working with QC/QA/R&D in the development of new raw material (RM) and finished good (FG) specs to bring in to compliance with regulations
    Working with account managers to help answer customer questions, concerns and/or provide further documentation if needed
    Reviewing ingredients/formulas for alternate markets based on regulatory requirements
    Reviewing technical documentation generated, from both internal and external sources, for international registrations r Reviewing international labels for compliance
    Follows Health & Safety Policies/SOPs including but not limited to the Safety Responsibilities Procedure
    Will comply with Good Manufacturing Practices in all GMP sensitive areas of Jamieson Laboratories Ltd. facilities
    ldentifying creative solutions for overcoming regulatory challenges
    Identifying new opportunities for lnternational sales within the regulatory environment

    Manage 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 Requirements
    Bachelor degree in Science/Biological Sciences
    Regulatory experience an asset
    Ability to understand and interpret technical documents
    Ability to use scientific judgement with minimal supervision
    Ability to multitask and complete work in a timely manner
    Excellent written and oral communication skills
    Strong organizational and administrative skills
    Proficient with computers. Working knowledge of MS Word, MS Excel, etc. and general ERP systems (such as QAD) Commitment to continuous professional improvement
    Ability to obtain results with minimal supervision in a team environment
    Team oriented
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