Regulatory Submission Specialist

Job Summary

A company is looking for a Regulatory Submission Project Management Specialist.

Key Responsibilities

• Schedule and manage routine regulatory submissions, including IND safety reports and clinical site documentation updates
• Monitor and track performance of the submission process for clinical site documentation
• Coordinate submission deliverables and manage overall completeness of scheduled submissions

Required Qualifications

• Bachelor's Degree with 0-2 years of relevant industry experience
• Recent pharmaceutical regulatory experience, preferably in submissions
• Strong knowledge of applicable Regulatory Agency regulations and guidelines (e.g., FDA, EMA, ICH)
• Experience with eCTD knowledge and submission processes
• Proficiency in MS Office applications, Adobe Acrobat, and electronic document management systems (eDMS)