Manager Regulatory Affairs (m/f)

REFERENZNUMMER:

374702/1

IHRE AUFGABEN:

-You are responsible for the management of all Regulatory Affairs (RA) activities in Germany to meet current and future RA objectives in alignment with the German Regulatory Affairs objectives
-You formulate short and long term vision for local RA function to ensure functional and internal cross-functions alignment
-You act as local RA expert to provide strategic input on the application of local regulations, review processes and submission requirements
-You take ownership for the content of local submission and maintain full awareness of all RA activities on local portfolio, ensuring project deadlines and performance standards are met
-You act as Merck representative with local Health Authorities for all regulatory matters

IHRE QUALIFIKATIONEN:

-Advanced degree in Pharmacy/Chemistry/Biology or other science-related field
-Profound experience in pharmaceutical regulatory affairs is required
-Working knowledge of key health authorities in Germany and surrounding European countries
-English (business fluent)

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager