Global Regulatory Submission Manager
2 months ago
Job Summary: We are seeking a highly skilled Global Regulatory Submission Manager to join our team at Novartis. As a key member of our regulatory affairs team, you will be responsible for leading and managing multiple and simultaneous global regulatory submissions in eCTD and non-eCTD formats.
Key Responsibilities:
- Lead and manage multiple and simultaneous global regulatory submissions in eCTD and non-eCTD formats.
- Drive cross-functional teams focused on the planning, overseeing compilation activities, and dispatch of worldwide regulatory HA submissions, anticipating technical obstacles, and developing solutions.
- Provide guidance to global project teams on worldwide HA submission format/requirements, filing strategy, eCTD document lifecycle management, and submission compilation workflows.
- Partner across multiple cross-functional functions, troubleshoot submission technical/quality issues, and manage the efficient use of global resources.
Requirements:
- 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.
- 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.
- Strong project management skills: DXC (eCTDxpress/Publisher), Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tool.
- Fluency in English.
About Novartis: 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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