Regulatory Affairs Mgr

AmgenIndia - HyderabadonsiteSalary not postedView the original posting at Amgen ↗

Career Category Regulatory Job Description Manager - International Regulatory Lead Role Name: Manager – International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT AMGEN Amgen 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 ROLE Role Description 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. Roles & Responsibilities - 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, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). - 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 clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. - Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. - Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. - Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. - Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. - Partners with peers to agree on product strategy including projected submission and approval time. - Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. - Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. - Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. - Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience · Doctorate degree OR · Master's degree and 3 years of relevant regional regulatory experience OR · Bachelor's degree and 5 years of relevant regional regulatory experience OR · Associate degree and 10 years of relevant regional regulatory experience OR · High school diploma/GED and 12 years of re

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