Manager, Regulatory Submission Project Management (RSPM)
On-site · Tokyo, Tokyo, Japan
Job Summary
The Manager, Regulatory Submission Project Management (RSPM) leads planning, execution, and review of regulatory operations activities, ensuring successful submission of regulatory documents to health authorities. Key responsibilities include collaborating with teams to create submission timelines, guiding teams in resolving issues related to submission documents, managing submission deliverables, reviewing submission content plans for compliance, and supporting various regulatory consultations. The ideal candidate has strong knowledge of regulatory agency regulations, excels in project management for submissions, and is proficient with submission systems and eCTD preparation.
Required Qualifications
- Bachelor's Degree
- At least six years of pharmaceutical industry or relevant experience
- Strong knowledge of Regulatory Agency regulations, guidelines, and specifications (e.g., PMDA, FDA, EMA, and ICH)
- Excellent project management and timeline management skills
- Experience with eCTD preparation and validation processes
- Strong proficiency with MS Office applications and Adobe Acrobat
Desired Qualifications
- Proficiency with systems like Veeva Vault RIM and docuBridge
- Strong knowledge of submission processes, eCTD guidelines, and regulatory tools
Additional Requirements
- Candidates must be able to work on-site
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