International Regulatory Lead (Manager)

International Regulatory Lead

Applyremote typeOn SitelocationsIndia - Hyderabadtime typeFull timeposted onPosted Todayjob requisition idR-242348Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.ABOUT THE ROLEThe 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 SummaryThe 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 ActivitiesSTRATEGY AND EXECUTIONAdvises 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 suppo