Executive Director, Regulatory Cmc

BridgeBio

Remote, US
$305,000 - $350,000 usd py
Remote with quarterly visits to the san francisco office.
Global cmc regulatory strategy
Regulatory submissions (ind/cta/maa/nda)
Health authority interactions
BridgeBio is seeking an Executive Director for Regulatory CMC to lead global regulatory activities for biotech products. The role involves defining regulatory strategies, ensuring quality submissions, and collaborating with cross-functional teams, all while promoting an innovative and boundary-pushing company culture

Job Summary

  • The Executive Director, Regulatory CMC provides strategic and operational leadership for global CMC regulatory activities across development and commercial products, partnering with key departments to ensure high-quality submissions and enable product lifecycle management.
  • Responsibilities include defining and executing global CMC regulatory strategies, leading the preparation and review of CMC sections for regulatory submissions, and managing health authority interactions for various global agencies.
  • BridgeBio offers market-leading compensation, comprehensive health benefits with 100% premium coverage, unlimited flexible paid time off, and opportunities for skill development and internal mobility.

Matching Summary

Match Score: 85

BridgeBio is seeking an Executive Director for Regulatory CMC to lead global regulatory activities for biotech products. The role involves defining regulatory strategies, ensuring quality submissions, and collaborating with cross-functional teams, all while promoting an innovative and boundary-pushing company culture.

Salary

$305,000 - $350,000 USD

Skills & Requirements

Must-have

  • Global CMC regulatory strategy
  • Regulatory submissions (IND/CTA/MAA/NDA)
  • Health authority interactions
  • CMC regulations and guidances
  • Cross-functional team leadership

Nice-to-have

  • Pioneering biotech approach
  • AI-powered tool adoption
  • Curiosity and experimentation
  • Defy convention

Key Requirements

  • 12-15+ years of relevant experience
  • Advanced degree in scientific discipline (PhD preferred)
  • Experience leading CMC strategy and authoring/reviewing Module 3
  • Experience with major global submissions (IND/CTA and marketing application)
  • Ability to lead cross-functional teams and influence senior stakeholders

Work Rights

Not specified

Tailored Resume

Cover Letter