We have an excellent opportunity for a Technical Regulatory Affairs Manager to join a company in the drug discovery industry in Basel. This position is offered on a contract basis between 6 to 12 months. The ideal candidate will execute with following tasks:
- Write and update the Module 2 (Quality Overall Summary) and the Module 3 (drug substance and drug product quality sections) of the CTD/NDA Applications
- Create Briefing Books and supportive documentation for Health Authority meetings (pre-IND, pre-NDA, End of Phase II, Scientific Advice meetings)
- Support and advise the project team regarding pharmaceutical development related to regulatory strategy for submission
