CMC Regulatory Sciences Lead – Biopharma Impact

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

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Hybrid work model

Health benefits for dependents

HSA with employer contributions

Fertility & family-forming benefits

Expanded mental health support

Flexible PTO and holidays

Job summary

BridgeBio Pharma, headquartered in San Francisco, seeks a Senior Manager/Associate Director to lead CMC Regulatory Sciences activities across subsidiaries, including Eidos Therapeutics. The role involves authoring and reviewing regulatory submissions and shaping strategies across global programs.

The position requires a PhD with 7+ years or BS/MS with 10+ years of experience in regulatory sciences, and a strong track record in regulatory affairs, cGMP, and cross-functional collaboration.

Qualifications

• Extensive regulatory writing and submission experience.
• Strong knowledge of regulatory guidelines (FDA/EMA/ICH).
• Experience with cGMP and drug substance/product development.

Responsibilities

• Collaborate with CMC teams to design drug substance and drug product control strategies.
• Author and review sections of clinical trial and marketing applications (IND/NDA/MAA) and post-approval changes.
• Prepare responses to health authority queries related to Quality sections.
• Maintain quality risk assessments per ICH M7, ICH Q3D, and nitrosamines guidance.
• Advise on starting materials, specifications, and process characterization.
• Identify regulatory issues impacting multiple projects and coordinate cross-team alignment.
• Apply AI tools to improve efficiency, quality, and consistency of submissions.
• Coordinate with International Regulatory Affairs on global filing strategies and timelines.

Skills

CMC Regulatory Sciences

Regulatory Writing

FDA/EMA/ICH Guidelines

cGMP Knowledge

Analytical Development

Regulatory Strategy

AI in Regulatory Submissions

Education

PhD with 7+ years relevant experience

BS/MS with 10+ years relevant experience

Job description

BridgeBio Pharma, headquartered in San Francisco, seeks a Senior Manager/Associate Director to lead CMC Regulatory Sciences activities across subsidiaries, including Eidos Therapeutics. The role involves authoring and reviewing regulatory submissions and shaping strategies across global programs.

The position requires a PhD with 7+ years or BS/MS with 10+ years of experience in regulatory sciences, and a strong track record in regulatory affairs, cGMP, and cross-functional collaboration.