RA QA Manager
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Utrecht Netherlands.
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
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.