Regulatory Submissions Manager

ICON

**
Minimum of 6 years experience in regulatory affairs
Prior experience with cta ind maa submissions
Bachelor's degree in scientific or healthcare field
** ICON is seeking a Regulatory Submissions Manager to join their Regulatory Affairs team, where the individual will provide regulatory guidance and manage submissions related to drug development. The role requires a minimum of six years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, emphasizing leadership and collaboration. **

Job Summary

  • ICON plc is a world-leading healthcare intelligence and clinical research organization seeking a Manager of Regulatory Affairs to join their diverse team.
  • The role involves leading regulatory activities and submissions independently while providing guidance across various stages of drug development including early development and post-approval phases.
  • ICON offers competitive benefits including health insurance, retirement planning, and a global Employee Assistance Programme focused on well-being and work-life balance.

Matching Summary

Match Score: 75

** ICON is seeking a Regulatory Submissions Manager to join their Regulatory Affairs team, where the individual will provide regulatory guidance and manage submissions related to drug development. The role requires a minimum of six years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, emphasizing leadership and collaboration. **

Skills & Requirements

Must-have

  • Minimum of 6 years experience in regulatory affairs
  • Prior experience with CTA IND MAA submissions
  • Bachelor's degree in scientific or healthcare field

Nice-to-have

  • Advanced degree preferred
  • Ability to lead internal teams independently
  • Strong understanding of global regulatory guidelines

Key Requirements

  • 6+ years pharmaceutical or biotech regulatory affairs experience
  • Bachelor's degree required; advanced degree preferred
  • Proven track record with CTA/IND/MAA submissions

Work Rights

Not specified

Tailored Resume

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