Are you a highly motivated individual? Looking to get the most out of your extensive Regulatory experience? Ready to work in a hands on environment and make a real difference to people’s lives?
THEN I HAVE THE OPPORTUNITY FOR YOU!
After a recent partnership with start-up Biotechnology Company, which focuses on the development of drugs to treat severe genetic disorders, I am looking for an experience Regulatory Affairs professional to join them in a director position.
The company are driven by changing lives through their innovative technology and entrepreneurism. As well as having a strong passion for using ground breaking science to development medicines that will transform the lives of patients and their loved ones.
As a Regulatory Affairs Director you will be accountable for the development and implementation of the regulatory strategy for products, and ensure the content, format and quality of regulatory submissions comply with the applicable regulations.
You will drive the preparation of regulatory applications, including orphan drug applications, INDs/CTAs, scientific advice, paediatric investigational plans and NDA/MAAs.
- Minimum of an undergraduate degree in scientific discipline
- Minimum of 10 years Regulatory Affairs experience
- Experience with orphan drugs and paediatric development plans
- Excellent knowledge of EU and US regulatory environments
- Strong knowledge and experience in all phases of drug development
If you are ready to work in an exciting and innovative environment within a very committed start-up organization then APPLY NOW!!