Associate Director, Regulatory Affairs - CMC

BridgeBio Pharma · Remote

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Role summary

Associate Director for Chemistry, Manufacturing, and Controls (CMC) regulatory affairs at BridgeBio's Eidos Therapeutics subsidiary. This remote role supports CMC regulatory strategy development and prepares dossier submissions for global health authorities, reporting to the Senior Director of Regulatory Affairs CMC.

What they're looking for

Demonstrated ability to work independently on regulatory processes and submissions
Knowledge of global CMC regulations, guidance, and drug development standards
Experience preparing CMC sections of regulatory dossiers and marketing applications
Cross-functional collaboration and health authority interaction experience
Project coordination and document workflow management skills

What you'll be doing

Develop global CMC regulatory strategies collaborating with management and subject-matter experts
Create and prepare CMC sections of regulatory dossiers for marketing applications
Coordinate timelines, author workflows, and approval processes for CMC documentation
Support health authority interactions including meeting requests and briefing book preparation
Provide input on regulatory strategy and responses to health authority CMC inquiries

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