Regulatory Affairs
Dr. Notghi Contract Research GmbH is an international acting contract research organization (CRO) with over 15 years of experience in the field of clinical studies. Our strengths include academic services in the areas of pharmacovigilance, pharmaceutical development, medical writing, as well as training and workshops on topics of clinical research.
As we continue to expand our business, we are currently seeking highly qualified and motivated individuals in the field Regulatory Affairs. We offer a very pleasant working environment and excellent development opportunities.
Key Accountabilities
- You are responsible for the processing of national and international registration processes
- Support in the preparation of registration dossiers and renewal applications and notifications of changes at home and abroad
- Maintenance of registration documents in electronic databases
- Communication with authorities and ethics committees
- Literature review
- Work closely with other departments
Qualifications and Experience
- Study of natural science, medicine or pharmacy or education in a relevant environment
- Several years of professional experience in Regulatory Affairs
- Very good knowledge of relevant regulations and guidelines
- Experience in approval procedures Europe (national, MRP, DCP, CP), national non-European authorization procedure, Regulatory Strategies
- Independent and structured work
- Very good German and English knowledge, other languages desirable
- Willingness to work in a team
Please send your application to: jobs@notghi.com or use our online application form.