Regulatory Strategy Lead

IQVIA

Us and eu regulatory strategy expertise
Authoring ind nda bla submissions
Leading cross-functional development teams
The role serves as a senior Regulatory Lead and Project Lead accountable for global drug development projects across the US and EU

Job Summary

  • The role serves as a senior Regulatory Lead and Project Lead accountable for global drug development projects across the US and EU.
  • Candidates must demonstrate deep hands-on expertise in authoring key regulatory submissions including US INDs, NDAs, BLAs, and EMA/UK MAA deliverables.
  • This position requires leading cross-functional matrix teams to integrate clinical, safety, CMC, and commercial inputs into executable development strategies.

Matching Summary

The role serves as a senior Regulatory Lead and Project Lead accountable for global drug development projects across the US and EU.

Skills & Requirements

Must-have

  • US and EU regulatory strategy expertise
  • Authoring IND NDA BLA submissions
  • Leading cross-functional development teams
  • Target Product Profile development
  • Clinical Development Plan creation
  • Orphan drug designation experience

Nice-to-have

  • Trusted client advisory skills
  • Mentoring junior colleagues
  • Business development proposal authoring
  • Resilience in high-pressure environments
  • Strategic trade-off decision making

Key Requirements

  • Master's degree in Life Sciences
  • Minimum 8 years relevant regulatory experience
  • Experience with FDA and EMA/UK procedures
  • Proven track record of project leadership

Work Rights

Not specified

Tailored Resume

Cover Letter