Regulatory Affairs Senior Manager| MEA

القاهرة - مصر

الراتب شهرياً: لم يكشف

تاريخ النشر: نُشرت قبل 2 يوم

عدد الوظائف الشاغرة: 1 عدد الوظائف الشاغرة

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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 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. safetydriven updates class labeling multimarket 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 highrisk 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 crossfunctional 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 tradeoffs and implementation timelines.

Qualifications:

Bachelors degree in pharmacy or related life sciences (required); advanced degree preferred.
Typically 810 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 multicountry 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.

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:

Senior 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 Senior Manager MEA

Scope

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. safetydriven updates class labeling multimarket 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 highrisk 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 crossfunctional 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 tradeoffs and implementation timelines.

Qualifications:

Bachelors degree in pharmacy or related life sciences (required); advanced degree preferred.
Typically 810 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 multicountry 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

Required Experience:

Senior 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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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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