Senior Manager – RegOps

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Red Nucleus

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Red Nucleus is a company specializing in healthcare and life sciences services, offering a wide range of advisory and scientific services. With over three decades of experience, they provide solutions across the life sciences product life cycle, aiming to improve health outcomes. Their services include market access and commercialization, medical communications, and learning and development. Red Nucleus also offers products like DirectusPRO and iTakeControl. They focus on supporting strategic and operational challenges in healthcare through their expertise in areas like Quality, Clinical, Safety, Regulatory, and Medical Affairs. The company employs a team of over 700 members dedicated to advancing knowledge and improving lives.

📋 Description

• 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