AD/Director, Regulatory Affairs CMC

BridgeBio Pharma · Remote

RoleLantern checked active

RegulatoryRemoteCompany career page

RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.

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

Privacy & handoff

This role links to BridgeBio Pharma's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.

What RoleLantern checked

This role is listed from an approved source. RoleLantern checks that the application link is live and how recently the role appeared — the employer has not confirmed it directly on RoleLantern.

RoleLantern checked active

RoleLantern checkedNeeds clarity

Date postedToday

Last source checkToday

Salary listedNeeds clarity

Location clearClear

Something look off? Let us know and we may ask the employer to verify it.

See how you match this role

Upload your CV to see which of this role's requirements your background supports, where there may be gaps, and what needs clarification. Private by default — we never sell your CV.

See my match