Senior Manager – RegOps
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Job Description
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.
Responsibilities:
- 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:
- 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:
- 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
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