HOW 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.Sr Associate Regulatory Affairs - based in EgyptLiveWhat 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 requirementsWith close supervision, implements the filing plan (MA and Lifecycle maintenance) for their countries, where applicableReviews 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 Regulatory Affairs Lead 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 applicableParticipates in local regulatory process improvements, initiatives, and trainingEstablishes regular contacts and interactions with Distributors (if applicable).WinWhat We Expect Of YouWe are all different, yet we all use our unique contributions to serve patients. The Sr Regulatory Affairs professional we seek is a teammate with these qualifications.Basic QualificationsBachelor`s degree in Pharmaceutical ScienceKnowledge of the Gulf legislation and regulationsAwareness of the registration procedures in region, post approval changes, extensions and renewalsKnowledge 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 QualificationsDegree and in-depth regulatory experience of the Gulf Markets (1-2 years experience)Depth knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.Experience interacting with regulatory agency in the Gulf marketsThriveWhat 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.