Sosu-job i Nordsjælland
Would you like to be exposed to topics within regulatory, development, production, quality and commercial and work with many different stakeholders? Do you like to be challenged and challenge others? Then you might be our new Specialist within Regulatory Affairs.
Improving health & quality of life
At Bavarian Nordic we work to develop innovative and safe vaccines to treat and prevent cancer and infectious diseases. Our aim is to improve health and quality of life for children and adults around the world. We hope that you will share this mission with us.
Experienced and dedicated colleagues
In Global Regulatory Affairs we are 14 employees. You will be a part of an ambitious CMC team consisting of 5 employees and will be reporting to the Senior Director of the team. In the CMC team we are responsible for writing the Quality Sections for IND/CTA and BLA/MAA Applications and for answering technical requests from the Health Authorities (e.g. FDA, EMA, Health Canada).
Many different scientific topics
In the role as Specialist you will have the following responsibilities and tasks:
- Write and update the Module 2 (Quality Overall Summary) and the Module 3 (Quality) of the eCTD
- Write and update the Quality part of the IMPD/IND/BLA/MAA for clinical trial applications and CMC variations
- Support preparation of Scientific Advice Briefi...