Career CategoryRegulatoryJob 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.Job purpose: As a member of this fast-pace, 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 e-labeling 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 analyticsManage Performance Excellence through collection, analyzing & disseminating relevant information to team(s) as appropriateParticipate in local regulatory process improvements initiativesBuild newsletter, annual Report, data analysis with follow up on Key Performance Indicators and MetricsEnsure delivery of right first time label source text for artwork creationSupport 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 regionAccess 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 formatPerform the role of source text owner/approver and artwork reviewer/approver in the systemTrigger 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 AffairsCurrent/ previous experience in working as part of an MNC employerPharmacist, biologist, chemist-medical backgroundFluent in English and Arabic for translation review purpose ( French is a huge plus)A minimum knowledge of Middle East Africa regulatory requirementsStrong communication skills (verbal & written) with ability to understand and communicate the scientific information and anticipate/prevent potential issuesConflict Management skillset & ability to deal with multiple stakeholders simultaneously.What You Can Expect Of UsAs 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 organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsApply now for a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comAmgen 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..