MEA Regulatory Affairs Sr Associate
نُشرت في :
06-05-2025
صاحب العمل نشط
1 وظيفة شاغرة
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيValid email field required
أرسل الوظائف
شارك هذه الوظيفة
أرسل لي وظائف مشابهة
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيValid email field required
أرسل الوظائف
الوصف الوظيفي
Career Category
RegulatoryJob 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 everbetter products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Job purpose:
As a member of this fastpace complex and dynamic region MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline inline and biosimilars; as well participating in labeling projects internally and externally for elabeling implementation;and execution of Regulatory Affairs processes in the local office.
Job Responsibilities:
Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems to ensure data standards are 100% accurate as to enable effective reporting and data analytics
Manage Performance Excellence through collection analyzing & disseminating relevant information to team(s) as appropriate
Participate in local regulatory process improvements initiatives
Build newsletter annual Report data analysis with follow up on Key Performance Indicators and Metrics
Ensure delivery of right first time label source text for artwork creation
Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
Ensure implementation of master artworks as per Amgen procedures SKU strategy and timelines with high quality to serve our patients in MENA region
Access the translation agency systems to request the label translation and track the job readiness and timelines.
Perform regional prescribing information translation review: 100% review of both content and format
Perform the role of source text owner/approver and artwork reviewer/approver in the system
Trigger the existing label revision when alerted by global RA team.
Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet label blister outer pack)
Collate distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
Qualifications:
Experience 2 years in Regulatory Affairs
Current/ previous experience in working as part of an MNC employer
Pharmacist biologist chemistmedical background
Fluent in English and Arabic for translation review purpose ( French is a huge plus)
A minimum knowledge of Middle East Africa regulatory requirements
Strong communication skills (verbal & written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues
Conflict Management skillset & ability to deal with multiple stakeholders simultaneously.
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 wellbeing.
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.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
.Required Experience:
Senior IC
نوع التوظيف
دوام كامل
المهارات المطلوبة
الإبلاغ عن هذه الوظيفة
إخلاء المسؤولية: د.جوب هو مجرد منصة تربط بين الباحثين عن عمل وأصحاب العمل. ننصح المتقدمين بإجراء بحث مستقل خاص بهم في أوراق اعتماد صاحب العمل المحتمل.
نحن نحرص على ألا يتم طلب أي مدفوعات مالية من قبل عملائنا، وبالتالي فإننا ننصح بعدم مشاركة أي معلومات شخصية أو متعلقة بالحسابات المصرفية مع أي طرف ثالث. إذا كنت تشك في وقوع أي احتيال أو سوء تصرف، فيرجى التواصل معنا من خلال تعبئة النموذج الموجود على الصفحة اتصل بنا
