Global Regulatory Submission Manager
2 weeks ago
Guided by our purpose to reimagine medicine to improve and extend people’s lives, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together The Role: Global Regulatory Submission Manager
This role offers hybrid working, requiring 3 days per week in person in our White City, London office. Ad-hoc working hours to overlap the India/US time zone as required. Please note we do not provide sponsorship or relocation support for this role. Major Accountabilities:
Lead and manage multiple and simultaneous global regulatory submissions in eCTD and non-eCTD formats components. Drive cross-functional teams focused on the planning, overseeing compilation activities, and dispatch of worldwide regulatory HA submissions, anticipating technical obstacles, and developing solutions. Negotiate timelines, manage global stakeholder expectations, publishing team, and leadership communications. Provide guidance to global project teams on worldwide HA submission format/requirements, filing strategy, eCTD document lifecycle management, and submission compilation workflows. Plan, manage and track delivery of submission components, coordinate submission publishing activities with publishing team, organize submission review and approvals. Partner across multiple cross-functional functions, troubleshoot submission technical/quality issues, and manage the efficient use of global resources. Organize, lead, and participate in both internal and external stakeholder meetings. Develop and implement solutions to create efficiencies and effectiveness. Your Experience Bachelor's degree in life sciences or relevant discipline. Regulatory affairs or regulatory submissions related experience in global HA regulatory formats and submissions publishing activities. Familiarity with the drug development process, global HA regulations/guidance e.g., FDA, ICH, EMA, MENA, CH. Proven enterprise mindset and quality driven. Strong interpersonal/project/time management skills and experience managing through complexities in a fast-paced, global cross-functional organization. Effectively works as part of a team environment or independently. Strong project management skills: Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Decisive, solution-oriented, pragmatic, customer-focused, readily adapts to changing priorities and composed under pressure. Working knowledge of publishing tools (e.g., DXC (eCTDxpress/Publisher), Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tool. Familiarity with submission publishing/compilation principles is ideal. Fluency in English.Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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