Regulatory Operations Sr. Project Manager, 規制提出プロジェクトマネージャー

This is a fully remote position, open to applicants in Japan.

📋 Description

• Planning and management of regulatory submission projects, including timeline oversight and progress tracking.

• Clarification of submission strategies and responsibilities through collaboration with cross-functional teams.

• Ensuring the quality and consistency of submission documents and addressing any issues that arise.

• Management and coordination of submission deliverables in collaboration with the regulatory publishing department and external vendors.

• Review of submission content and verification of compliance with regulatory guidelines in various countries.

• Support for the submission of PMDA consultations, clinical trial notifications, change applications, minor change notifications, and approval applications.

• Maintenance and improvement of submission templates and standard processes.

• Promotion of standardization and consistency in regulatory submissions.

• Management of documents and metadata within the EDMS (Electronic Document Management System).

⛳️ Requirements

• Bachelor's degree or higher.

• Over 6 years of relevant experience in the pharmaceutical industry (Regulatory Affairs / Submission / Operations).

• In-depth knowledge of the regulatory submission process and eCTD guidelines.

• Skills in project management and schedule management.

• Experience using submission-related systems such as Veeva Vault RIM and docuBridge.

• Practical experience in eCTD preparation and validation processes.

• High proficiency in MS Office and Adobe Acrobat.

• Japanese: Native level.

• English: Business level (reading, writing, and meeting participation).

🏝️ Benefits

• Fully remote work.

• Health insurance.

• Annual paid leave.