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Regulatory Affairs Specialist

  1. Eindohoven
  1. Contract
Competitive
25169MBU
  1. Drug Safety / Pharmacovigilance
Date Posted23 Jul 2020
Regulatory Affairs Specialists  – Global Pharmaceutical Company – long term contract

Do you want to be part of one of the top 10 best pharmaceutical companies in the world? If so, this could be your chance! One of our global pharmaceutical clients is looking for a Regulatory Affairs specialist on all levels. 

This is a truly exciting project, which when complete will contribute to the manufacturing of a veterinary treatment.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Develop and execute project plans to ensure that processes, as well as regulatory information systems and platforms, are brought in line with the new EU Telematics landscape as defined by the EMA (IDMP, UPD, SPOR, CESSP). The scope of the project includes biological (vaccine) as well as pharmaceutical products.
  • Maintaining close contact with internal stakeholder groups, such as Global Regulatory Affairs, EU Country Regulatory Affairs (CORAs), Pharmacovigilance, IT, Sales
  • Assess regulatory impact for approved products and work closely with other Global Regulatory Affairs department to ensure preparation and execution of product variations if required

 Desirable Experience:
  • Academic level with proven related working experience in Life Sciences (e.g. pharmacy, biology, chemistry, biochemistry, supply chain)
  • Profound experience in the pharmaceutical industry with a focus on regulatory data management, quality management, manufacturing, supply chain or compliance
  • Knowledge on EU Telematics landscape (e.g. IDMP, UPD, SPOR, CESSP)
  • Experience in project management and experience to work in multi-disciplinary project teams
  • Experience with regulatory information systems and platforms (i.e.: CESSP, Veeva) and EU registration processes is an advantage.

 Please apply now for more information!! 



The candidate must have the rights to work in the location stated in the job advert.

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