Regulatory Operations Specialist

Job Summary

A company is looking for a Regulatory Operations Senior Specialist to join their team remotely in the US.

Key Responsibilities

• Provides support to global submission teams and internal stakeholders for submission components
• Manages review, compilation, publishing, and utilizes specialized software tools for submissions
• Monitors agency regulations to ensure compliance with submission formats and structures

Required Qualifications, Training, and Education

• Experience in regulatory operations or related field
• Proficiency in using specialized software tools for submission management
• Knowledge of global regulatory guidance and submission requirements
• Ability to work collaboratively with cross-functional teams
• Experience in quality assurance for regulatory submissions