After an exciting partnership with startup, Biotechnology Company focused in the development of drugs to treat sever genetic disorders, I am looking to speak with experienced Regulatory Affairs professionals to join the company in a Director position.
Founded by a father after the diagnosis of his son, the company began with a goal of developing a treatment for cystic fibrosis, and has now developed a large pipeline of programs to treat various genetic diseases including Usher syndrome and Alzheimer’s.
Based in Leiden, the company are driven by changing lives through the use of groundbreaking sciences, innovative technology and entrepreneurism, with a strong dedication to transforming the lives of patients and their loved ones.
As a Director of a small, family company you will be accountable for the development and implementation of Regulatory strategy, and actively participate in the facilitation of effective partnerships.
- Preparation of Regulatory applications, including Orphan drug applications, INDs/CTAs, Scientific advice, Pediatric Investigational Plans and NDA/MAAs.
- Communicate with internal/external partners, including EMA, FDA and other Regulatory authorities
- Ensure the content, qualifications and format of Regulatory submissions comply with applicable regulations/guidelines
If you are ready to work in a supportive, family based company and utilize your extensive experience, GET IN CONTACT NOW!