Career CategoryRegulatoryJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.LiveWhat you will doLet’s do this. Let’s change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance :Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirementsLocal coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.Execution of the preparation, delivery, and electronic archiving of documentation for inclusion in local regulatory submissions.Coordination and execution of Regulatory Affairs processes and deliverables in the local office.Reviews promotional and non-promotional materialsExchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely mannerPartners with international Regulatory Leads (IRL) to support the regulatory development, registration, and lifecycle management of all Amgen moleculesPartners with peers to ensure consistency on proceduresAssists locally in Healthcare Compliance activities, where applicableParticipate in local regulatory process improvements, initiatives, and trainingOverseas external vendor/contractor relationships, where applicableWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Associate Regulatory Affairs professional we seek is a teammate with these qualifications.Basic Qualifications:Bachelor`s degree in Pharmaceutical ScienceKnowledge of Regulatory PrinciplesWorking with policies, procedures and SOP’sComprehensive understanding of regulatory activities and how they impact other projects and/or processesUnderstanding of drug developmentDemonstrate ability to work in teamsAbility to understand and communicate scientific/clinical informationPreferred Qualifications:Regulatory experience of the Gulf Markets (1 year experience)Knowledge of legislation and regulations relating to medicinal products in the Gulf Markets.ThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided 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 accommodation..