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  • Location

    Boxmeer, Netherlands

  • Job title:

    Associate Specialist

  • Sector:

  • Job ref:

    44611

  • Startdate:

    2020-08-03

The Company 
This (bio-)pharmaceutical company is located in Boxmeer. They develop and produce veterinary vaccines and medication. 
A big number of important vaccine development functions all under one roof. Research, Development, Production, Quality Control, Logistics, Marketing and Sales are all located in Boxmeer. With a big team this company often shows how innovative they are, collaborating with different teams and locations all over the world.

Role Description 
Within the Global Regulatory Affairs department they are looking for an Associate Specialist. This department is responsible for the regulatory data and document infrastructure, electronic publishing of registration files and the global management of labelling documents for Biologicals and Pharmaceutical products.

You will participate in a multidisciplinary project team, ensuring that all regulatory submissions within the EU are following the new upcoming regulations. Supporting the implementation of new business processes and update/create relevant SOPs.


Responsibilities 
  • Support the implementation of new business processes
  • Update and create relevant SOPs
  • Support the Global Regulatory Affairs team in collecting and analyzing regulatory information in different IT systems, assessing impact for registered products
  • Ensure alignment between SPOR data and in-house Global information systems, update product related information as needed
  • Contribute to the preparation of regulatory submissions/variations if required
  • Prepare and provide training on new requirements and e-submission platform to relevant stakeholders
 

Requirements

  • Bachelor Degree in Life Sciences
  • Minimal 2 years' of experience in the pharmaceutical industry with a focus on Regulatory, Data Management, Compliance or Quality Management
  • Experience with registrations processes
  • Preferred experience with Regulatory Information Systems and Platforms

Other Information 
If you want to apply please submit your CV via the button below.

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