Regulatory Affairs Manager
Responsible for the regulatory management of projects for specific therapeutic areas, including:
• Management of registration activities (National and EU) for the Oncology and Cardiovascular products
• Preparation of local submissions and updating of the regulatory databases and electronic library system
• Product information and promotional materials review in compliance with the company’s Pharma Code.
• Participation in several multidisciplinary Brand Teams giving strategic regulatory insight
• Regulatory Liaison on a joint-venture project for the Diabetes area (BMS-AZ Alliance).