Regulatory Submission Manager

Century Center

Not specified
Global regulatory submissions
Ectd, nees, and paper formats
Cross-functional team collaboration
Century Center is seeking a Regulatory Submission Manager to oversee and coordinate global regulatory submissions for investigational and marketed products. The ideal candidate should possess significant regulatory experience, particularly in publishing and submission management, and demonstrate strong organizational skills in a collaborative, matrixed environment

Job Summary

  • Contribute to the delivery of high-quality, timely global regulatory submissions supporting investigational and marketed products.
  • Coordinate submission priorities and planning across business units and product portfolios.
  • You will thrive in this role if you bring: A Bachelor’s degree (or higher) in Life Sciences, Pharmacy, or a related discipline.

Matching Summary

Match Score: 85

Century Center is seeking a Regulatory Submission Manager to oversee and coordinate global regulatory submissions for investigational and marketed products. The ideal candidate should possess significant regulatory experience, particularly in publishing and submission management, and demonstrate strong organizational skills in a collaborative, matrixed environment.

Skills & Requirements

Must-have

  • Global regulatory submissions
  • eCTD, NEES, and paper formats
  • Cross-functional team collaboration
  • Vendor oversight and performance monitoring
  • ICH guidelines knowledge

Nice-to-have

  • Advancing regulatory excellence
  • Meaningful work and global collaboration
  • Culture of curiosity and empathy

Key Requirements

  • Bachelor's degree or higher
  • 5+ years pharmaceutical regulatory experience
  • Experience preparing dossiers for core and international markets
  • Working knowledge of health authority requirements (EU, US, Canada, Switzerland, Australia)
  • Familiarity with Veeva RIM Suite
  • Experience managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

Cover Letter