Director, Regulatory Affairs - Cmc

ICON

Multiple Locations, US
Fully remote
Regulatory cmc submission management
Technical expertise in biologics development
Experience with inds/ndas/blas submissions
ICON plc is a world-leading healthcare intelligence and clinical research organization fostering an inclusive environment driving innovation and excellence

Job Summary

  • ICON plc is a world-leading healthcare intelligence and clinical research organization fostering an inclusive environment driving innovation and excellence.
  • The Director will serve as a technical expert in biologics development, manage regulatory submissions, and provide strategic advice to clients while leading communications with agencies and project teams.
  • ICON offers competitive salary and a range of benefits focused on well-being and work-life balance, including health insurance, retirement planning, and global employee assistance programs.

Matching Summary

ICON plc is a world-leading healthcare intelligence and clinical research organization fostering an inclusive environment driving innovation and excellence.

Skills & Requirements

Must-have

  • Regulatory CMC submission management
  • Technical expertise in biologics development
  • Experience with INDs/NDAs/BLAs submissions
  • Knowledge of US FDA drug listing processes
  • Global regulatory environment experience

Nice-to-have

  • People management experience
  • Business development support
  • Certification in regulatory affairs
  • Experience with diverse dosage forms
  • Remote work flexibility

Key Requirements

  • Bachelor’s degree in life sciences or healthcare
  • Advanced degree beneficial (MSc, PhD, M.D., Pharm.D., MBA)
  • Regulatory experience in US, EU, Canada
  • Demonstrable regulatory CMC role experience
  • RAC certification or post-secondary education beneficial

Work Rights

Not specified

Tailored Resume

Cover Letter