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  • Location

    Noord - Brabant, Netherlands

  • Job title:

    regulatory affairs officer

  • Sector:

    Pharmaceutical

  • Job ref:

    44060

  • Startdate:

    2020-05-14

The Company

The company has a Biotech and Pharmaceutical operations site. They are one of the biggest innovative companies in the Netherlands and they are specialized in vaccines, biological therapies and medicines.

Role description
You will make a contribution towards the preparation of any critical regulatory documentation of specified regulatory submissions.

Responsibilities

  • Reviewing and identify documents providing advice on changes to
  • Review and identify documents to determine the appropriate classifications
  • Negotiating with regulatory authorities
  • Setting timelines for license variations and renewal approvals
  • Act as a contact person for internal and external stakeholders
Requirements
  • Min. Bachelor’s degree 
  • Experience in a related field and/or industry
  • Knowledge of scientific R&D documents within Life Science industry
  • Knowledge and understanding of EPA, FDA GxP, FDA CFR 21 Part 11OECD GLP, USDA, and VICH regulations and guidelines
Other information
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post

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