Great opportunity for a bilingual regulatory affairs professional to make an impact on a growing team!
Job Detail
Job Description
Responsibilities:
1. Communicate with customers to receive and price project orders.
2. Coordination of customer deliverables across internal global client 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 client 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)
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