Job Description

Red Nucleus is hiring a Senior Manager / Associate Director, RegOps to join our global team. This role will be fully remote.

Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 800 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.

At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves. Our culture is about meaningful work, a true sense of community, and fun. We love to celebrate our people and we are proud to have been Internationally recognized as a “Great Place to Work".

How You Will Contribute

In this position, you will be working with our Scientific Services team. For more information, please visit Scientific Services.

Red Nucleus is a global strategic partner to pharmaceutical and biotechnology companies across the full product lifecycle, connecting scientific and regulatory services, market access, medical communications, and learning and development to help our clients advance and protect patient health. Within our Regulatory Operations practice, we act as a remote extension of our clients' internal teams — publishing, submitting, and managing complex global regulatory filings with the accuracy and speed the industry demands.

We are looking for an experienced Regulatory Operations professional to join and help lead our Japan team, at the Senior Manager or Associate Director level depending on experience. This is a client-facing, people-leadership role owning eCTD publishing and submission management, global regulatory information systems, and the team that delivers this work day to day. Working closely with the Head, Regulatory Operations, you will take responsibility for the quality, timeliness, and compliance of major regulatory submissions — including electronic study data — for our Japan-based clients.

This is a backfill role supporting business continuity ahead of a planned team transition later this year, with an emphasis on early onboarding, effective knowledge transfer, and minimal disruption to ongoing client engagements.

What You'll Own

• 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

What We're Looking For

This is a hands-on, client-facing leadership role. We are looking for proven regulatory operations capability across the areas below.

Core Skills (must-have)

• 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

Desired Attributes

• Adaptability in a fast-paced global environment
• Strong stakeholder management and cross-functional collaboration skills
• Effective prioritization and multitasking capabilities
• Proactive problem-solving and leadership mindset

Education and Experience

• Bachelor's degree or equivalent hands-on experience in Life Sciences, Regulatory Affairs, or a related field
• Proven track record leading regulatory operations teams that support major global submissions
• Experience operating in a client-facing, remote, cross-cultural team environment
• Experience within the Life Sciences / Pharmaceutical industry required

*This job description captures the essential functions of this role as of July 2026. Management reserves the right to modify it as business needs evolve.

What You Will Enjoy at Red Nucleus

• Comprehensive benefits and wellness programs focused on healthy lifestyles
• Generous paid time off, employee assistance programs and flexible work arrangements
• Performance driven environment including professional development and transfer opportunities
• People first culture fostering self expression, diversity, and a growth mindset
• Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones and anything else that is meaningful to our employees
• Support of the community organizations you are passionate about
• Ongoing programs and events designed to bring our global team together

Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit. We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.

To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.

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