Career CategoryRegulatoryJob DescriptionJob DescriptionApply, obtain and maintain regulatory approvals for products within Amgen’s portfolio, including CTNs, MAAs, renewals, variations, and other life cycle management activities.Ensure all regulatory submissions are delivered on time and comply with Amgen corporate standards as well as local regulatory requirements.Develop and implement product related regulatory strategies, Regulatory Affairs processes, and activity plans in accordance with national legislation and regulatory requirementsLead interactions and negotiations with Regulatory Authorities to facilitate and optimize regulatory approvals.Participate the in the local implementation of key Regulatory initiatives and projects.Maintains an awareness of emerging legislation, regulatory policies, and technical Regulatory guidance relating to Amgen’s pipeline and product portfolio.Provide regulatory support to Therapeutic Areas and Scientific Affairs activities.Where applicable, oversee external vendors and contractors.Feedback on relevant Regulatory Intelligence and insights to International Regulatory AffairsKnowledge and SkillsStrong regulatory expertise in national, MRP, centralized procedures, biotechnology products, and medical devicesProven experience in interacting with regulatory authoritiesSolid understanding of policies, procedures and SOPsIn-depth knowledge of national legislation and regulations relating to medicinal productsUnderstanding of Europe and US regulatory pathways, including MAAs, variations, extensions, and renewalsKnowledge of drug developmentExperience managing complex regulatory projectsDemonstrated scientific and technical expertiseStrong leadershipExcellent verbal and written communication skillsEffective team work and collaboration skillsStrong negotiation and stakeholder management abilitiesAbility to proactively identify, anticipate, and mitigate potential issuesBasic QualificationsDoctorate degree and a minimum of 5 years of directly related experience; orMaster’s degree and a minimum of 8 years of directly related experience; orBachelor’s degree and a minimum of 12 years of directly related experiencePreferred Qualifications:Experience working in MNCs,Experience in BiologicsExperience in OncologyExperience in medical devices registration fieldProficiency in multiple languages.