Regulatory QA Manager

Bedrijfsnaam: -
Plaatsingsdatum: 29/09/2018
Standplaats: -


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 and Biotechnology organisation, based in Liège Belgium.The CompanyOur client is a professional Biotechnology and Pharmaceutical organization, based in Liege Belgium. They are searching for breakthrough medicines for high unmet medical needs.

Role DescriptionThe purpose of this job is:
- Take responsibility and fulfill 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 accountable and representative 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 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 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.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
5 - 10 jaar
Contactgegevens :