About this role
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
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