Description
We are looking for a
Regulatory Affairs Manager (m/f)
Reference: -en
Start: 12/14
Duration: 24 MM
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- Perform regulatory due diligence for defined product dossiers and establish gap analyses against country submission content plans for countries in scope
- Develop and implement appropriate regulatory strategies to ensure successful product submission & approval
- Act as a counterpart towards regulatory contact from the external partner and ensure productive and efficient interactions
- Define regulatory work package for defined products and coordinate planning of submissions
- Manage applications for new marketing authorization, answer to questions & any other local request, variations and renewals
Your qualifications
- Degree in a Life Science or related discipline
- Experience with LCM activities in at least two regions (e.g. Europe, LATAM, APAC)
- Profound pharmaceutical industry experience
- Prior experience in performing regulatory due diligence
- Business fluent in English and German
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager