Senior Director, Regulatory Affairs - Early Development

RayzeBio

San Diego, CA, US
Remote - united states - us: $241,768 - $292,966; ...
Fully remote
Early development regulatory strategy
Clinical and nonclinical regulatory strategy
Authoring regulatory documents
This Global Regulatory Lead (GRL) position will oversee and/or manage Early Development regulatory functions and direct reports within RayzeBio

Job Summary

  • This Global Regulatory Lead (GRL) position will oversee and/or manage Early Development regulatory functions and direct reports within RayzeBio.
  • Lead the preparation and submission of regulatory filings (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications).
  • Our benefits include: Health Coverage, Wellbeing Support, Financial Well-being and Protection, and Work-life benefits.

Matching Summary

This Global Regulatory Lead (GRL) position will oversee and/or manage Early Development regulatory functions and direct reports within RayzeBio.

Salary

Remote - United States - US: $241,768 - $292,966; San Diego - RayzeBio - CA: $261,110 - $316,404; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Early Development regulatory strategy
  • clinical and nonclinical regulatory strategy
  • authoring regulatory documents
  • Health Authority Interactions
  • Global Regulatory Lead

Nice-to-have

  • nimble, pioneering spirit
  • collaboration is at the heart
  • make an immediate impact
  • adapt in a dynamic environment

Key Requirements

  • 10 or more years of hands-on regulatory experience
  • Experience with nonclinical and clinical regulatory strategy
  • Bachelor’s degree or higher

Work Rights

Not specified

Tailored Resume

Cover Letter