Senior Manager / Associate Director - RegOps

Red Nucleus

22d • Remote

About The Position

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".

Requirements

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

Nice To Haves

• 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.

Responsibilities

• 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.
• Administer and continuously improve the global regulatory information management systems and processes that support the Japan team and its clients.
• Support the evaluation, configuration, and rollout of regulatory technology platforms such as Documentum, Veeva Vault, Insight Manager, Insight Publisher, and docuBridge.
• Manage, coach, and develop a team of regulatory operations professionals, building bench strength and succession readiness for the Japan team.
• Serve as a trusted point of contact on client engagements, partnering cross-functionally to align on priorities, timelines, and risk.
• Work fluently across Microsoft Excel, Word, PowerPoint, and Visio, plus Adobe Acrobat, Evermap or ISIToolbox, and eCTD publishing tools to prepare submission-ready documentation.
• Bridge Japanese- and English-speaking stakeholders, ensuring regulatory content and communications are accurate and clearly understood across teams.

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
• Support of the community organizations you are passionate about
• Ongoing programs and events designed to bring our global team together

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree