[Hiring] Senior Manager / Associate Director - RegOps @Red Nucleus

Role Description

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

In this position, you will be working with our Scientific Services team.

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.

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.

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.

Qualifications

• 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

Requirements

• 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

Benefits

• 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