Description
We are looking for a
Regulatory Affairs Manager (generic products) (m/f)
Reference: -en
Start: asap
Duration: 1 MM++
Place: in Berlin and homeoffice
Branch: Pharmazeutische Industrie
Your tasks:
- Assessment on the regulation for the registration of excipients in generic products (parenteral application)
- Consultation concerning the regulatory requirements for different types of excipients in particular chelating agents or scavengers
- Evaluation of needs for Europe, Japan, Korea, China and USA
Your qualifications
- University degree in natural sciences, or equivalent
- Strong experience in a global Regulatory Affairs function, including experience within EU, Japan, Korea, China and USA
- Familiarity with generic products
- Excellent knowledge in English language
Skills:
- Regulatory affairs assistant
Keywords: regulation excipients generic parenteral Europe Korea China USA