Regulatory Affairs Manager| MEA

Career Category

Job Description

HOW 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 Manager| MEA

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.
• Current or previous experience within MNCs is a must.
• 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.

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.