Company: SIRE Life Sciences
Location: Utrecht

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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Utrecht Netherlands.


The Company

The company is medical and scientific driven for high quality medical output, continuing the growth of their company.

Role Description

The purpose of this job is:

  • Act as Quality Management representative
  • Support regulatory submissions worldwide
  • Ensure compliance of design control (global level)


Responsibilities

  • Ensure design control compliance
  • Lead the qualification and monitoring of suppliers
  • Identify applicable quality and regulatory requirements
  • Review and approve all project deliverables; promotional and labelling material


Requirements

  • Minimum Master degree (or higher) in a scientific field
  • A minimum of 5 years’ experience in regulatory affairs in a pharmaceutical or biotech industry
  • Good experience with GDP, Regulatory, and Pharmacovigilance
  • Good knowledge of international legislation, and thorough understanding of drug and biologics guidelines and regulations
  • Excellent communication skills in English, and Dutch