The Associate Consultant / Submission Lead
• is responsible for the management and coordination of global submission documentation across
new and existing accounts.
• may also participate in or lead Regulatory Information Management or Systems projects related
to global submission documentation.
• will be working alongside partners, subject matter experts, and industry specialists to ensure that
all deliverables meet customer expectations.
• will be expected to actively contribute to business transformation, process optimizations and
system improvements.
The role will require representation of Red Nucleus in addressing customer business requirements and
needs.
Your Responsibilities
The Associate Consultant / Submission Lead will have many responsibilities including:
1. Communicate with customers to receive and price project orders.
2. Coordination of customer deliverables across internal global Red Nucleus teams.
3. Translation of submission requirements and information from Japanese to English and English to
Japanese.
4. Provide global expertise on requirements for electronic document management, submission
planning, report publishing, eCTD compilation, and management of approval information.
5. Project Management across all R&D contributors to global submissions.
6. Manage regional Japan eCTD submissions and support global eCTD submissions as a Lead
Publisher.
7. “Hands-On” submission-ready publishing of documents.
8. Proactively communicate requirements and issues to be considered to the Submission Team and
contribute to achieving realistic timelines.
9. Proactively collect necessary information from the Submission Team and plan all submission
management related activities.
10. Proactively communicate with clients on submission requirements for eCTD.
11. Perform quality checking of documents and regulatory submissions to ensure compliance with
submission-ready standards.
12. Compile and publish regulatory submissions in accordance with current standards and processes
using agreed upon tools.
13. Analyze submissions and track and record life-cycle information in accordance with standards.
14. Keep updated on regulatory authorities’ requirements on technical/format aspects of submissions
worldwide and ensure their incorporation into Red Nucleus standards.
15. Participate on or lead special project teams (e.g., skill work, standards).
Requirements
1. Fluent in Japanese and English languages
2. 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.
3. Experience assisting in project management for major submissions (J-NDA, US-NDA, EU-MAA,
etc.).
4. Understanding of drug development documents.
5. At least 3 years of experience with global regulatory information management and systems.
6. Experience assisting with the implementation of a regulatory system such as, Documentum, Veeva
Vault, docuBridge, etc.
7. Experience assisting in the migration of documents and submissions from one regulatory system to
another.
8. Proficient in Microsoft Suite software including Excel, Word, PowerPoint, Visio
9. Proficient in Adobe Acrobat, Evermap or ISIToolbox, and eCTD publishing tool
10. Bachelor’s degree (minimum requirement)
Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit. We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.
To learn more about working at Red Nucleus, please visit Careers I Red Nucleus.
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