Manager - International Regulatory Lead

Career Category Regulatory Job Description ABOUT THE ROLE The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to  - optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Job Summary The International Regulatory Lead (Manager) is assigned to lead one or more Amgen products. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen. Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals. Develop the international regulatory strategy and contribute to Global regulatory plans. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support and advise on the local label strategy and alignment to cCDS/reference label. Build effective relationships and communication paths across global, regional, local and functional organizations. Enable efficiencies and seamless execution across the international countries. Contribute to process improvement projects, as assigned. Key Activities STRATEGY AND EXECUTION Advises Global teams on regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, expedited regulatory designations, compassionate use and pediatric plan). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains CTA/MA documentation. May author documents/redact documents to support a regulatory filing. Leads the internal discussions related with Agency meetings and in accordance with GRT strategy (and communicates outcomes back to GRT and others, as applicable). Directs the development of the international product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance, precedents and competitor labeling. Manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.