Senior Manager – RegOps

Red Nucleus

Senior Manager / Associate Director, RegOps managing regulatory operations for pharmaceutical clients in a remote setting. Leading eCTD publishing, submissions, and people management for Japan-based team.

Posted 7/25/2026full-timeRemote • 🇯🇵 JapanSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in eCTD Publishing and Submission Management, ensuring compliance and timely delivery of regulatory submissions. Proficient in managing regulatory information systems and leading teams while effectively communicating in both Japanese and English.

Highest-signal resume keywords

ECTD PublishingRegulatory Information ManagementRegulatory Technology ImplementationPeople ManagementBilingual Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory OperationsDocument ManagementSubmission ManagementGlobal Regulatory ComplianceRegulatory Technology Implementation

Soft Skills

Team LeadershipStakeholder ManagementCross-Functional Collaboration

Tools & Technologies

DocumentumVeeva VaultInsight ManagerInsight PublisherDocuBridgeMicrosoft ExcelMicrosoft WordMicrosoft PowerPointMicrosoft VisioAdobe Acrobat

Industry Keywords

Pharmaceutical IndustryRegulatory SubmissionsECTD Publishing ToolsRegulatory Information Systems

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

eCTD Publishing & Submission Management — own end-to-end publishing, submission, and document management for major global regulatory submissions, including electronic study data, ensuring accuracy, compliance, and on-time delivery
Regulatory Information Management & Systems — administer and continuously improve the global regulatory information management systems and processes that support the Japan team and its clients
Regulatory Technology Implementation — support the evaluation, configuration, and rollout of regulatory technology platforms such as Documentum, Veeva Vault, Insight Manager, Insight Publisher, and docuBridge
People Leadership — manage, coach, and develop a team of regulatory operations professionals, building bench strength and succession readiness for the Japan team
Stakeholder & Client Management — serve as a trusted point of contact on client engagements, partnering cross-functionally to align on priorities, timelines, and risk
Tools & Documentation — work fluently across Microsoft Excel, Word, PowerPoint, and Visio, plus Adobe Acrobat, Evermap or ISIToolbox, and eCTD publishing tools to prepare submission-ready documentation
Bilingual Communication — bridge Japanese- and English-speaking stakeholders, ensuring regulatory content and communications are accurate and clearly understood across teams

Requirements

What you’ll need

Pharmaceutical industry experience — at least 10 years of experience in the pharmaceutical industry with a focus in Regulatory Operations
People management — at least 5–10 years of people management experience
eCTD publishing and submissions — at least 5+ years of experience with eCTD publishing, submitting, and managing documents for major submissions, including electronic study data
Global regulatory information management — at least 5+ years of experience with global regulatory information management and systems
Regulatory technology — experience assisting with the implementation of regulatory technology such as Documentum, Veeva Vault, Insight Manager, Insight Publisher, docuBridge, or equivalent
Tools proficiency — proficient in Microsoft Excel, Word, PowerPoint, and Visio, and in Adobe Acrobat, Evermap or ISIToolbox, and an eCTD publishing tool
Language — fluent in Japanese and English.

Benefits

Comp & perks

Comprehensive benefits and wellness programs focused on healthy lifestyles
Generous paid time off
Employee assistance programs
Flexible work arrangements
Performance driven environment including professional development and transfer opportunities
People first culture fostering self expression, diversity, and a growth mindset
Celebrations!
Support of the community organizations you are passionate about
Ongoing programs and events designed to bring our global team together