MEA Regulatory Affairs Sr Associate
Amgen · Cairo, Egypt
RegulatoryFull-timeCompany career page
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Role summary
Amgen seeks a Senior Associate in Regulatory Affairs for the Middle East and North Africa region to manage labeling, packaging, and regulatory documentation for its pharmaceutical portfolio. The role involves coordinating product lifecycle activities, ensuring compliance with regional requirements, and supporting regulatory submissions and product launches.
What they're looking for
- 2+ years regulatory affairs experience
- Background in pharmacy, biology, or chemistry
- Fluent in English and Arabic; French advantageous
- Knowledge of Middle East and Africa regulatory requirements
- Strong written and verbal communication skills
- Experience working in multinational organizations
- Conflict management and stakeholder engagement abilities
What you'll be doing
- Manage labeling and packaging for pipeline, inline, and biosimilar products across MENA region
- Maintain regulatory systems and platforms with accurate data for reporting and analytics
- Coordinate translation and review of product labeling and prescribing information
- Support regulatory filings, product launches, and lifecycle management documentation
- Provide regional product information and artwork approval as source text owner
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.