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Iselin

    Regulatory Affairs Specialist - Iselin, United States - Brenntag

    Brenntag
    Brenntag Iselin, United States

    3 weeks ago

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    Description

    Stage Picture:

    JobTitle:

    Regulatory Affairs Specialist - Pharma

    Location:

    South Plainfield/USA

    Employment Type:

    Employee

    Regulatory Affairs Specialist - Pharma

    Our team in South Plainfield 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 anenvironment where the best people want to work, where they can turn theirpassion into their job and realize their full potential.
  • Individual development,on-the-job training, and development programs designed to help ouremployees grow in their careers.
  • Competitive pay andincentives.
  • Various healthcare planoptions as well as 401(k).
    • INTERESTED?

    We look forward receiving your application.

    Brenntag provides equalemployment opportunities to qualified applicants and employees without regardto race, color, religion, sex, sexual orientation, gender identity, nationalorigin, protected veteran status, disability or any other status protected byapplicable federal, state or local law.

    Brenntag North America, Inc. and its subsidiaries useE-verify, a government-run, web-based system that allows employers to confirmthe eligibility of their employees to work in the United States.For moreinformation, please go to https://www.e- or view the poster at https://e-

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