Global Program Regulatory Manager NOVJP00025849 (m/f)

REFERENZNUMMER:

367462/11

IHRE AUFGABEN:

-Support the DRA Global Program Team (GPT)
-Execute regulatory plans in line with global regulatory strategy

IHRE QUALIFIKATIONEN:

-Science based Bachelor's or Master's/advanced degree (MD, Ph D, PharmD) preferred
-Fluency in English as a business language; additional language skills are an asset
-Experience with regulatory submission and approval processes in one or more major regions
-Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry
-Experience in HA negotiations and regulatory operational expertise
-Prior involvement in regulatory and drug/biologic development, spanning activities in Phases I-IV in the following areas: Innovation in regulatory strategy; Post-marketing/brand optimization; Strategies and commercial awareness; Dossier submissions and approvals; Drug regulatory submission and commercialization in the respective region; Analysis and interpretation and safety data

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager, Project manager