Senior Manager / Associate Director - RegOps
RemoteJapan
JapanRemoteFull TimeSenior LevelMedium
Full TimeSenior LevelMedium
Job Summary
Lead the Japan regulatory operations team by owning end-to-end eCTD publishing, submission management, and document control for major global filings. Administer and improve global regulatory information systems while supporting the rollout of platforms like Documentum, Veeva Vault, and Insight Manager. Manage and develop a team of professionals, serving as a trusted bilingual point of contact for Japanese and English-speaking stakeholders to align on priorities and risks. Ensure accuracy, timeliness, and compliance for client engagements during a planned team transition.
Required 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
- 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
Desired Qualifications
- 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
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