Senior Manager Regulatory Operations

Job Summary

A company is looking for a Senior Manager, Regulatory Operations and Publishing.

Key Responsibilities

• Assist in the preparation of regulatory submission documents in compliance with global regulatory requirements
• Manage the preparation and submission of promotional material to the U.S. FDA, ensuring compliance and accuracy
• Coordinate with external publishing vendors for timely delivery of high-quality regulatory submissions

Required Qualifications

• Bachelor's degree and 5+ years of experience in Regulatory Operations
• Expert level skills in Word processing, formatting, and PDF publishing for electronic submissions
• Experience with electronic document management and publishing systems
• Proficiency with MS Word and Adobe is a must
• Ability to work independently and efficiently