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 Support monitoring and tracking of submission processes for clinical site documentation Coordinate publications for submissions and manage overall completeness of scheduled submissions Required Qualifications Bachelor's Degree 0-2 years of industry and/or relevant experience Strong knowledge of applicable Regulatory Agency regulations and guidelines (e.g., FDA, EMA, ICH) Experience with submission processes and systems Knowledge of eCTD and document management systems, including VEEVA Vault and MS Office applications
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
Support monitoring and tracking of submission processes for clinical site documentation
Coordinate publications for submissions and manage overall completeness of scheduled submissions
Required Qualifications
Bachelor's Degree
0-2 years of industry and/or relevant experience
Strong knowledge of applicable Regulatory Agency regulations and guidelines (e.g., FDA, EMA, ICH)
Experience with submission processes and systems
Knowledge of eCTD and document management systems, including VEEVA Vault and MS Office applications
