Sr. Associate Regulatory Affairs
2 weeks ago
**Labeling and packaging activities management for Middle East North African region for Amgen portfolio**
- Perform label management within the system from CDS (product core data sheet) update to variation/MAA submission in the region
- Ensure delivery of right first time label source text for artwork creation
- 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 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 with end to end labeling process ownership
- Trigger the existing label revision when alerted by global RA team and support planning.
- Support in making product ready for supply by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
- support launching new products in the MEA region.
- **Coordination and execution of Regulatory Affairs processes and deliverables in the local office**
- Disseminate 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.
- Local SOPs redaction for labeling management.
- **Track and trace intelligence gathering and execution**
- GS1 knowledge and execution of the track and trace as per country requirements in the MEA region
- aggregation and master data management of Amgen products supplied across MEA region.
**Job Requirements**:
- Pharmacist, biologist, chemist-medical background
- 2-3 years’ experience in a similar role
- Fluent in English, Arabic and preferred French for translation review purpose
- A minimum knowledge of Middle East Africa regulatory requirements
- 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
- Cultural awareness and sensitivity with ability to resolve conflicts and develop course of action.
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 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.
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