Senior Manager – RegOps

This is a fully remote position, open to applicants in Japan.

📋 Description

• eCTD Publishing & Submission Management — take ownership of the complete publishing, submission, and document management process for significant global regulatory submissions, which includes electronic study data, ensuring precision, compliance, and timely delivery.

• Regulatory Information Management & Systems — manage and enhance the global regulatory information management systems and procedures that support the Japan team and its clients.

• Regulatory Technology Implementation — assist in the assessment, configuration, and deployment of regulatory technology platforms such as Documentum, Veeva Vault, Insight Manager, Insight Publisher, and docuBridge.

• People Leadership — oversee, mentor, and develop a team of regulatory operations specialists, fostering bench strength and succession readiness for the Japan team.

• Stakeholder & Client Management — act as a reliable point of contact for client engagements, collaborating across functions to align on priorities, timelines, and risks.

• Tools & Documentation — utilize Microsoft Excel, Word, PowerPoint, and Visio, in addition to Adobe Acrobat, Evermap or ISIToolbox, and eCTD publishing tools to create submission-ready documentation.

• Bilingual Communication — connect Japanese- and English-speaking stakeholders, ensuring that regulatory content and communications are precise and effectively understood across teams.

⛳️ Requirements

• Pharmaceutical industry experience — a minimum of 10 years in the pharmaceutical sector with a specialization in Regulatory Operations.

• People management — between 5 to 10 years of experience in managing teams.

• eCTD publishing and submissions — at least 5 years of experience in eCTD publishing, submission, and document management for major submissions, including electronic study data.

• Global regulatory information management — a minimum of 5 years of experience working with global regulatory information management and systems.

• Regulatory technology — experience in assisting with the implementation of regulatory technology platforms such as Documentum, Veeva Vault, Insight Manager, Insight Publisher, docuBridge, or similar systems.

• Tools proficiency — skilled in Microsoft Excel, Word, PowerPoint, and Visio, as well as Adobe Acrobat, Evermap or ISIToolbox, and an eCTD publishing tool.

• Language — fluency in both Japanese and English.

🏝️ Benefits

• Comprehensive benefits and wellness programs aimed at promoting healthy lifestyles.

• Generous paid time off.

• Employee assistance programs.

• Flexible work arrangements.

• Performance-driven environment that includes opportunities for professional development and transfer.

• People-first culture that encourages self-expression, diversity, and a growth mindset.

• Celebrations!

• Support for community organizations you are passionate about.

• Ongoing programs and events designed to unite our global team.