Senior Manager, Regulatory Information Systems

Sarepta Therapeutics

United States
Base: $136,000 - $170,000 py; bonus/equity: not sp...
Hybrid
8+ years regulatory information management experience
Expert proficiency with veeva rim suite applications
Deep knowledge of ectd publishing and global guidelines
The role involves leading critical activities related to Sarepta's Regulatory Information Management System to support global regulatory submissions

Job Summary

  • The role involves leading critical activities related to Sarepta's Regulatory Information Management System to support global regulatory submissions.
  • Candidates must ensure RIMS is used effectively across the organization while maintaining compliance with internal procedures and global regulatory expectations.
  • Sarepta offers a culture that supports work-life integration and provides comprehensive benefits including physical, emotional, and financial wellness resources.

Matching Summary

The role involves leading critical activities related to Sarepta's Regulatory Information Management System to support global regulatory submissions.

Salary

Base: $136,000 - $170,000 per year; Bonus/Equity: Not specified; Benefits: Comprehensive package including wellness and caregiver support

Skills & Requirements

Must-have

  • 8+ years regulatory information management experience
  • Expert proficiency with Veeva RIM suite applications
  • Deep knowledge of eCTD publishing and global guidelines
  • Experience with validated computer systems change controls
  • Strong background in document management and archiving

Nice-to-have

  • Ability to integrate AI and emerging technologies
  • Proactive aptitude for solving complex problems
  • Experience attending industry conferences for trends
  • Adaptive communication skills influencing without authority

Key Requirements

  • BA or BS degree or equivalent
  • 8 or more years of relevant experience
  • Authorized to work in the U.S.

Work Rights

Must be authorized to work in the U.S.

Tailored Resume

Cover Letter