Regulatory Affairs Sr Mgr

Job description

Career CategoryRegulatoryJob DescriptionJob 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 .