Amgen MEA Associate Regulatory Affairs in Egypt
Responsible for Management of regulatory activities management for Middle East & Africa for Amgen portfolio pipeline, inline & mature products
Coordination and execution of Regulatory Affairs Performance Excellence
Systems Management to deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics
Support efficiently the different marketing application & products life cycle management filings/approvals by providing regional support in a timely manner
Performance Excellence Management through collection, analyzing & disseminating relevant information to team(s) as appropriate
Participate in local regulatory process improvements initiatives
Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
Build & share newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
Perform Publishing and System driven activities
Support MEA Director in meeting agenda management, , presentations and data collection
Knowledge & Skills:
Medical Background with Project Management Skills
Fluent in English and Arabic, French is a plus
Minimum knowledge of Middle East Africa regulatory requirements
Hard worker, fast learner, positive attitude, team spirit, willing to take on challenges, details oriented.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.