SIRE Life Sciences®

RA QA Manager

Location: Netherlands
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

Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
SIRE Life Sciences®

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