Regulatory Affairs Manager| MEA

القاهرة - مصر

الراتب شهرياً: لم يكشف

تاريخ النشر: نُشرت قبل 2 يوم

عدد الوظائف الشاغرة: 1 عدد الوظائف الشاغرة

سجل للتقديم

ملخص الوظيفة

Career Category

Regulatory

Job Description

HOW MIGHT YOU DEFY IMAGINATION If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Regulatory Affairs Manager MEA

Scope:

Accountable for endtoend 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 rightfirsttime 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 supplyreadiness 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 inspectionready documentation.
Monitor and report operational metrics (e.g. rightfirsttime labels cycle time ontime delivery) and drive corrective actions for recurring defects or bottlenecks.
Support biosimilars labeling redaction/maintenance activities (as applicable to assigned portfolio).
Support trackandtrace/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:

Bachelors degree in Pharmacy or related life sciences (required); advanced degree is an advantage.
Typically 48 years of Regulatory Affairs experience with strong handson 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 multicountry 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 crossfunctional 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.

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.

Required Experience:

Manager

Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATION If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global co...

Career Category

Regulatory

Job Description

Regulatory Affairs Manager MEA

Scope:

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 rightfirsttime 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 supplyreadiness 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 inspectionready documentation.
Monitor and report operational metrics (e.g. rightfirsttime labels cycle time ontime delivery) and drive corrective actions for recurring defects or bottlenecks.
Support biosimilars labeling redaction/maintenance activities (as applicable to assigned portfolio).
Support trackandtrace/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:

Bachelors degree in Pharmacy or related life sciences (required); advanced degree is an advantage.
Typically 48 years of Regulatory Affairs experience with strong handson 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 multicountry 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 crossfunctional 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

Required Experience:

Manager

اعرض المزيد

المهارات المطلوبة

مراجعة/ تدقيق/ تنقيح
أدوبي أكروبات
FDA Regulations
Manufacturing & Controls
التكنولوجيا الحيوية
Clinical Trials
البحث والتطوير
GLP
cGMP
تطوير المنتجات
الكيمياء
Writing Skills

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عن الشركة

Amgen

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... اعرض المزيد

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