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Associate Regulatory Affairs Mea

4 months ago

مصر, Egypt Amgen Full time

**Job Summary**:

- Coordination and execution of Regulatory Affairs processes and deliverables in the local office: publishing, SharePoint maintenance, statistics analysis, reporting.
- Labeling and packaging activities management for Middle East North African region for Amgen portfolio

**Key Activities**:

- 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
- Performance Excellence Management through collection, analyzing & disseminating relevant information to team(s) as appropriate
- Participate in local regulatory process improvements initiatives
- Build & share newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
- Intelligence Gathering
- Perform Publishing and System driven activities
- Ensure delivery of right first time label source text for artwork creation
- Support efficiently products life cycle management by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
- Perform label management within the system from CDS (product core data sheet) update to variation submission in the region
- Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
- Access the translation agency systems to request the label translation and track the job readiness and timelines.
- Perform regional prescribing information translation review: 100% review of both content and format
- Perform the role of source text owner/approver and artwork reviewer/approver in the system
- Trigger the existing label revision when alerted by global RA team.
- Disseminate relevant information to team(s) as appropriate
- 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.
- Provide centralized support for SPO maintenance, statistical analysis, reporting monthly and annually.

**Requirements**:

- Pharmacist, biologist, chemist-medical background with Project Management Skills
- Fluent in English and Arabic for translation review purpose, French is an advantage
- Hard worker, fast learner, positive attitude, team spirit, willing to take on challenges, details oriented.
- Strong communication skills both oral and written, with ability to understand and communicate the scientific information and anticipate/prevent potential issues

Join Us

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 diseases, 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.