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.
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
- 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.
- 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