Description
We are looking for a
Regulatory Affairs Professional (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Bavaria
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- To be the EU RA representative in global development teams and provide regulatory guidance and strategy for assigned projects
- To plan, lead and manage regulatory submissions during development and life cycle management (including maintenance), e.g. CTAs and amendments, MAAs and variations, to European and other assigned authorities
- To act as the primary regulatory contact person for authorities
Your qualifications
- Regulatory Affairs professional with experience in the pharmaceutical industry and in-depth experience in global regulatory affairs with focus on EU requirements
- Therapeutic area experience in oncology
- Strong understanding of all areas of global drug development and respective regulatory requirements from early to late stage development
- Preparation and handling of scientific advice, orphan drug and PIP procedures and other regulatory submissions
Skills:
- Regulatory affairs manager