Regulatory Submission Specialist

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)