Career CategoryRegulatoryJob DescriptionJob DescriptionApplying, obtaining and maintaining regulatory approvals for products within Amgen’s portfolio, including CTN, MAA, renewal, variations of product’s life cycle management.Ensure that regulatory submissions are made on time and meet Amgen corporate standards and local regulatory requirements.Developing (with manager’s guidance) and implementing product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirementsUndertake interactions and negotiations with Regulatory Authorities, to optimize regulatory approvals.Participate in the local implementation of key Regulatory projects.Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen pipeline.Provide regulatory support for Therapeutic Areas/Scientific Affairs activities.Where applicable, oversee external vendor/contractor relationships.Feedback on any Regulatory Intelligence to International Regulatory AffairsKnowledge and SkillsRegulatory expertise in national, MRP, centralized and biotechnology products, medical devicesInteractions with regulatory authoritiesWorking with policies, procedures and SOPsKnowledge of national legislation and regulations relating to medicinal productsUnderstanding of the registration procedures in Europe and US for MAA, variations, extensions and renewalsUnderstanding of drug developmentExperience managing regulatory processesScientific / Technical ExcellenceSupervisory SkillsCommunication Skills: Oral and WrittenTeam WorkNegotiation SkillsAbility to anticipate and prevent potential issuesBasic QualificationsDoctorate degreeORMaster’s degree and 3 years of directly related experienceORBachelor’s degree and 5 years of directly related experienceORAssociate’s degree and 10 years of directly related experiencePreferred Qualifications:Experience in MNCs,Experience in biologicsExperience in medical devices registration fieldMulti-lingual.