Utrecht/Den Bosch, Netherlands
Regulatory Affairs Manager CMC
Helene de Vries
Helene de Vries
The companyThis biotech start-up creates and develops next generation T cells, engaging specific antibodies for the treatment of cancer. With cutting-edge research they are now looking to develop a candidate for clinical testing, broaden the current pipeline. And bring two new compounds to clinical trial in the coming two years. In this team you will work together with a group of experienced leaders and professionals with a proven track-record of success in their field of business. Do you want to be a part of this team?
Within this role you will bring knowledge on regulatory guidelines on New Bioligical Entities. Preparing regulatory submissions including CTD, IMPD, CTA and IND and documents for regulatory agencies with a focus on CMC.
- Connect with (inter-)national health authorities
- Provide input in the development programs on the regulatory strategy needed for phase I and phase II submissions
- Responsible for the set up of a document management system
- Assemble and maintain product development information
- Represent the company in internal and external meetings
- Master or PhD in Biotechnology or Biology
- Over 5 years' of Regulatory Affairs experience
- Proven Project Management skills
- Fluent in English, Dutch is a plus
Are you a pro-active person with an open personality? Not afraid to take on new challenges whilst keeping an overview of all the processes? Contact me and upload your CV via the apply button.