Regulatory Affairs Manager

Amgen

Scope:

Accountable for end to end execution of compliant, accurate, and timely local product labeling and packaging deliverables across assigned MEA markets. Ensures alignment with Global Core Labeling (GCL) and company labeling governance while incorporating local Health Authority requirements, language conventions, and lifecycle changes.

Key Responsibilities:

• Own and execute local labeling activities for assigned products/country clusters (e.g., SmPC/PI, PIL/leaflet, carton/label text, IFU), ensuring content accuracy, completeness, and compliance.
• Translate global core updates into local implementation plans: perform impact assessments, draft/redline local texts, coordinate review/approval, and support submission strategy for labeling variations/line extensions.
• Act as local/regional source text owner for artwork creation: deliver right first time source texts and maintain traceability from CDS/CCDS/GCL changes to country label implementation.
• Coordinate packaging and artwork lifecycle activities (leaflet, label, blister, outer pack): initiate and manage updates, support shared pack/SKU strategy execution, and ensure supply readiness timelines are met.
• Manage translation workflows (including engaging translation agency systems): request translations, track readiness, and perform 100% translation review for both content and format (as required for regional languages).
• Execute labeling/artwork review and approval tasks in designated systems (e.g., Veeva Vault, RIM/Regulatory Information Management, artwork management tools), maintaining version control and inspection ready documentation.
• Monitor and report operational metrics (e.g., right first time labels, cycle time, on time delivery) and drive corrective actions for recurring defects or bottlenecks.
• Support biosimilars labeling redaction/maintenance activities (as applicable to assigned portfolio).
• Support track and trace/serialization intelligence gathering and execution for assigned clusters; ensure packaging/labeling requirements are reflected in artworks and implementation plans.
• Draft, update, and/or support local SOPs and work instructions related to labeling management; ensure adherence to internal procedures and quality standards.
• Identify labeling and packaging risks (compliance, timelines, translations, artwork quality) and proactively propose mitigations; escalate issues per governance.

Qualifications:

• Bachelor s degree in Pharmacy or related life sciences (required); advanced degree is an advantage.
• Typically 4 8+ years of Regulatory Affairs experience with strong hands on labeling and artwork/packaging lifecycle management.
• Knowledge of Middle East & Africa regulatory requirements and practical experience coordinating multi country implementations.
• Language skills: English (required); French literacy strongly preferred; Arabic preferred when the role includes Arabic translation review responsibilities.
• Demonstrated proficiency working in regulated document and workflow systems (e.g., Veeva Vault, RIM tools) and in cross functional matrix environments.
• Skills/behaviors: detail orientation, planning/priority management, proactive risk management, clear written/oral communication, cultural awareness, and a quality mindset.