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 has seen great growth in recent years. A global player in the Biopharmaceutical market, based in the region of Utrecht. Always searching for breakthrough medicines for high unmet medical needs.

Role Description

The purpose of this job is:

  • Taking responsibility and fulfilling all regulatory obligations for the marketed products, including drug safety obligations;
  • Implement and manage the Quality management system
  • Act as Quality and Regulatory representative
  • Support regulatory submissions worldwide


Responsibilities

  • Act as local Drug Regulatory Affairs responsible for and with regard to any regulatory discussions.
  • Create and update national product information, prescriber kits, and train employees in this.
  • Monitor Global requirements regarding RA, drug safety, quality assurance, compliance and pricing.
  • Local lead responsibility for the handling of technical product complaints and product recalls.
  • Act as primary contact person for local employees on all QA matters.


Requirements

  • Minimum MSc.
  • 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