Regulatory Affairs Senior Manager

Amgen

Scope:

Provides strategic leadership and oversight for labeling activities across MEA markets, ensuring regional alignment to Global Labeling Strategy and governance. Drives risk management, operational excellence, capability building, and timely patient access across diverse regulatory environments.

Key Responsibilities:

• Define and maintain MEA regional labeling strategy and operational priorities across clusters/products, aligned to global governance and business priorities (launches, safety updates, lifecycle changes).
• Serve as the senior MEA labeling representative in global governance forums and labeling working groups; advocate for regional needs and enable timely global decisions.
• Provide strategic oversight and direction for complex labeling changes (e.g., safety driven updates, class labeling, multi market harmonization, shared pack strategy) and launch readiness .
• Lead and approve regional impact assessments for global core label changes; set implementation approach, timelines, and escalation pathways for high risk updates.
• Accountable for inspection readiness: ensure compliant processes, robust documentation/traceability, audit support, and timely closure of observations/CAPAs related to labeling and packaging controls.
• Drive continuous improvement, standardization, and efficiency across MEA labeling processes (e.g., templates, playbooks, KPI frameworks, quality checks) to improve predictability and reduce rework.
• Provide leadership for vendor and partner performance (e.g., translation agencies, artwork houses) including quality expectations, service levels, and continuous improvement actions (budget oversight where applicable).
• Ensure effective cross functional coordination across Regulatory, Safety, Quality, Supply Chain, and affiliate teams to maintain supply continuity and patient access.
• People leadership: recruit/structure resources as needed, coach and develop L5/junior team members, set objectives, conduct performance reviews, and build succession and capability plans.
• Acts as escalation point for labeling risks, delays, and Health Authority interactions that threaten compliance, supply continuity, or patient safety.
• Influences global and regional stakeholders to align decisions, trade offs, and implementation timelines.