Description
We are looking for a
DRA Project Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Acquire and maintain an overview of relevant regulatory requirements
- Creation and finalization of key regulatory documents (IMPD) as well as ensuring submission to HA (EU), scientific advice packages, Module 1 documents for EU and support for global submissions MAA
- Represent DRA in lifecycle, CT and other project-related meetings
Your qualifications
- Bachelor degree in life sciences, medicine, pharmacy or equivalent
- Basic knowledge of regulatory legislation and guidelines
- Familiarity with clinical trial methodology
- Excellent English skills, both verbal and written
Skills:
- Regulatory affairs assistant
Keywords: Regulatory Affairs Assistent