Senior Manager, CMC Regulatory Science — Hybrid/Remote

BridgeBio; San Francisco (CA); Hybrid; USD 188,000 - 215,000; Full time

Benefits offered by this job

Hybrid work model

401(k) with employer match

ESPP

Health premiums for you and dependents

Paid holidays

Job summary

BridgeBio is seeking a Senior Manager/Associate Director in CMC Regulatory Sciences in the San Francisco area. You will work with CMCtechnical teams and Regulatory Affairs to design control strategies aligned with ICH and regional requirements throughout the product lifecycle.

The role involves authoring regulatory sections and responding to health authorities, with a focus on risk assessment and materials characterization.

Qualifications

• PhD with 7+ years relevant experience; or BS/MS with 10+ years relevant experience.
• Background in regulatory authoring for drug substance and drug product.
• Familiarity with FDA, EMA, and ICH guidelines for INDs/NDAs/MAAs.
• Ability to interpret regulatory requirements and guide development teams.

Responsibilities

• Collaborate with CMC teams to design and implement regulatory strategies across lifecycle.
• Author and review drug substance/product sections for clinical trial applications and marketing authorizations.
• Respond to health authority queries related to Quality sections of regulatory submissions.
• Prepare quality risk assessments per ICH M7, Q3D, and nitrosamines guidelines.
• Advise on starting materials, specifications, and manufacturing process characterization.
• Identify regulatory issues with cross-project impact and influence teams accordingly.
• Apply AI-enabled tools to improve efficiency and quality of submissions.
• Coordinate with International Regulatory Affairs and Supply Chain on global launch sequences.

Skills

CMC regulatory strategy

Regulatory authoring

FDA/EMA/ICH guidance

Cross-functional leadership

Education

PhD with 7+ years

BS/MS with 10+ years

Job description

BridgeBio is seeking a Senior Manager/Associate Director in CMC Regulatory Sciences in the San Francisco area. You will work with CMCtechnical teams and Regulatory Affairs to design control strategies aligned with ICH and regional requirements throughout the product lifecycle.

The role involves authoring regulatory sections and responding to health authorities, with a focus on risk assessment and materials characterization.