Description
We are looking for a
Regulatory Affairs Manager (m/f)
Reference: -en
Start: asap
Duration: 9 MM++
Place: in Hesse
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Perform regulatory due diligence for defined product dossiers and establish gap analysis against country submission content plans for countries in scope
- Develop and implement appropriate regulatory strategies to ensure successful product submission and approval
- Define regulatory work packages for defined products and coordinate planning of submissions
- Manage applications for new marketing authorisation, answer to questions and 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 fluency in English
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager