Regulatory Affairs Senior Mgr

**Career Category** ------------------- Regulatory **Job Description** ------------------- **Job Description** * Apply, 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 requirements * Lead 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 Affairs **Knowledge and Skills** * Strong regulatory expertise in national, MRP, centralized procedures, biotechnology products, and medical devices * Proven experience in interacting with regulatory authorities * Solid understanding of  policies, procedures and SOPs * In-depth knowledge of national legislation and regulations relating to medicinal products * Understanding of Europe and US regulatory pathways, including MAAs, variations, extensions, and renewals * Knowledge of drug development * Experience managing complex regulatory projects * Demonstrated scientific and technical expertise * Strong leadership * Excellent verbal and written communication skills * Effective team work and collaboration skills * Strong negotiation and stakeholder management abilities * Ability to proactively identify, anticipate, and mitigate potential issues **Basic Qualifications** * Doctorate degree and a minimum of 5 years of directly related experience; or * Master’s degree and a minimum of 8 years of directly related experience; or * Bachelor’s degree and a minimum of 12 years of directly related experience Preferred Qualifications: * Experience working in MNCs, * Experience in Biologics * Experience in Oncology * Experience in medical devices registration field * Proficiency in multiple languages .