Career Category

Regulatory

Job DescriptionHOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Regulatory Affairs Senior Manager| MEA

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.

Qualifications:

• Bachelor’s degree in pharmacy or related life sciences (required); advanced degree preferred.
• Typically, 8–10+ years of Regulatory Affairs experience with demonstrated regional or global labeling leadership.
• Current or previous experience within MNCs is a must.
• Proven strategic thinking, governance participation, and risk management capability across complex, multi‑country portfolios.
• Language skills: English (required); French literacy strongly preferred; additional regional languages an advantage.
• Demonstrated people leadership (coaching, performance management) and ability to influence without authority across matrix teams.

Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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