BridgeBio

Executive Director, Regulatory CMC

BridgeBio

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $320,000 - $350,000 per year

Job Level

Lead

About the role

  • Provide strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products
  • Partner closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management.
  • Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests)
  • Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.)
  • Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.

Requirements

  • Advanced degree in a relevant scientific discipline (PhD strongly preferred; MS/BS with significant experience considered)
  • Typically 12–15+ years of relevant experience in CMC regulatory affairs within biotech/pharma (biologics, small molecules, cell/gene therapy, or combination products—tailor as needed)
  • Demonstrated success leading CMC strategy and authoring/reviewing Module 3 for major global submissions (IND/CTA and at least one marketing application strongly preferred)
  • Deep knowledge of global CMC regulations and guidances (ICH Q-series, regional requirements, post-approval change frameworks)
  • Proven ability to lead cross-functional teams and influence senior stakeholders in a matrix environment
  • Excellent writing, communication, and executive presentation skills
  • You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.
Benefits
  • a market-competitive total rewards package
  • base pay
  • annual performance bonus
  • company equity
  • generous health benefits
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC regulatory affairsModule 3 authoringIND/CTA submissionsmarketing application submissionsglobal CMC regulationsICH Q-seriespost-approval change frameworksbiologicssmall moleculescell/gene therapy
Soft Skills
strategic leadershipoperational leadershipcross-functional team leadershipinfluencing senior stakeholderswriting skillscommunication skillsexecutive presentation skillscuriosityadaptability
Certifications
PhDMSBS