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    Regulatory Affairs Specialist – Pharma - Toronto, Canada - Brenntag

    Brenntag
    Brenntag Toronto, Canada

    2 days ago

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    Description

    Our team in Etobicoke currently has an opening for a Regulatory Affairs Specialist – Pharma

    YOUR ROLE & RESPONSIBILITIES

  • Supporting the regional Pharma division Sales Team on topics including regulatory, legal, compliance, quality and product safety.
  • Completion of technical and regulatory information requests from customers within the pharmaceutical industry (questionnaires, supply chain agreements, QAA's & TA's) in and English.
  • Contribute as part of team to maintenance of EMEA document management system to keep product and supplier information up to date.
  • Request product and supplier information directly from manufacturers and indirectly via other internal channels.
  • Process Change Control Notifications.
  • Maintain customer specific information such as completed questionnaires, supply chain agreements, QAA's, TA's in the designated database.
  • Creation and ongoing update of product regulatory information in standardized information packs.
  • Support of customer, regulatory and 3rd party audits.
  • Reporting and documenting customer requests via KPIs.

    • YOUR PROFILE

    Education and Experience:

  • 2 years previous experience working with regulatory documentation.
  • Knowledge of ISO9001, food safety or GxP systems.
  • University degree in life sciences
  • Knowledge of pharmaceutical industry requirements and regulations on APIs, Excipients and starting materials.
  • Previous experience with the FDA (or another national competent authority) and their requirements.
  • Team player, strong communication and interpersonal skills, with ability to work across all levels, and functions

    • OUR OFFER

  • We aim to create an environment where the best people want to work, where they can turn their passion into their job and realize their full potential.
  • Individual development, on-the-job training, and development programs designed to help our employees grow in their careers.
  • Competitive pay and incentives.
  • Various healthcare plan options as well as 401(k).
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