Associate Consultant - Submission Lead

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Red Nucleus

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market access • regulatory operations • advisory • clinical research • commercialization

501 - 1000

Description

• Responsible for the management and coordination of global submission documentation across new and existing accounts. • Participate in or lead Regulatory Information Management or Systems projects related to global submission documentation. • Work alongside partners, subject matter experts, and industry specialists to ensure that all deliverables meet customer expectations. • Actively contribute to business transformation, process optimizations and system improvements. • Represent Red Nucleus in addressing customer business requirements and needs. • Communicate with customers to receive and price project orders. • Coordination of customer deliverables across internal global Red Nucleus teams. • Translation of submission requirements and information from Japanese to English and English to Japanese. • Provide global expertise on requirements for electronic document management, submission planning, report publishing, eCTD compilation, and management of approval information. • Project Management across all R&D contributors to global submissions. • Manage regional Japan eCTD submissions and support global eCTD submissions as a Lead Publisher. • “Hands-On” submission-ready publishing of documents. • Proactively communicate requirements and issues to be considered to the Submission Team and contribute to achieving realistic timelines. • Proactively collect necessary information from the Submission Team and plan all submission management related activities. • Proactively communicate with clients on submission requirements for eCTD. • Perform quality checking of documents and regulatory submissions to ensure compliance with submission-ready standards. • Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools. • Analyze submissions and track and record life-cycle information in accordance with standards. • Keep updated on regulatory authorities’ requirements on technical/format aspects of submissions worldwide and ensure their incorporation into Red Nucleus standards. • Participate on or lead special project teams (e.g., skill work, standards).

Requirements

• Fluent in Japanese and English languages • At least 5 years of experience in the pharmaceutical industry with a focus in regulatory operations such as eCTD publishing, submission NDA and electronic study data etc. in the Gateway portal, and managing documents in a document repository system. • Experience assisting in project management for major submissions (J-NDA, US-NDA, EU-MAA, etc.). • Understanding of drug development documents. • At least 3 years of experience with global regulatory information management and systems. • Experience assisting with the implementation of a regulatory system such as, Documentum, Veeva Vault, docuBridge, etc. • Experience assisting in the migration of documents and submissions from one regulatory system to another. • Proficient in Microsoft Suite software including Excel, Word, PowerPoint, Visio • Proficient in Adobe Acrobat, Evermap or ISIToolbox, and eCTD publishing tool • Bachelor’s degree (minimum requirement)