Beschreibung
Senior Manager - Global Regulatory Affairs - Germany
My Client are a global pharmaceuticals organisation who are looking for an experienced regulatory affairs project manager to assist them in developing a new regulatory strategy across the globe. THey are looking for an experienced professional with extensive pharma/healthcare knowledge and the ability to work closely with global teams to define and then deliver global solutions.
PURPOSE OF THE ROLE:
- Assist in preparation and execution of global regulatory strategies
- Manage the submission and approval of applications for clinical trials (WW), amendments, prior to marketing application activities such as PIP, orphan designation and others.
MAIN INTERFACES (ranked by order of importance):
INTERNALLY:
- Other Global Regulatory functions from different development hubs
- Global Development functions, in different hubs
- Research functions
- Portfolio and Business Development functions
- Global Manufacture and Supply functions
- Commercial Europe, US, Japan
- Global Marketing functions
EXTERNALLY:
- Regulatory Affairs in affiliates
- Health Authorities in ICH countries
- Other Pharmaceutical Companies
KEY TASKS & RESPONSIBILITIES:
Requested start date
Scheduled project end