CMC Regulatory Sciences Lead (Hybrid/Remote)

JobRx, Inc.; Owens (OH); 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

Comprehensive health benefits

Job summary

BridgeBio is seeking a Senior Manager/Associate Director for CMC Regulatory Sciences. You will lead cross-functional regulatory activities across Drug Substance, Drug Product, and Analytical Development, authoring sections for global applications and guiding responses to health authorities.

The role emphasizes interaction with international regulatory teams, development partners, and compliance with ICH and FDA/EMA guidelines, while leveraging AI tools to improve submissions and data governance.

Qualifications

• PhD or BS/MS with substantial regulatory experience in CMC.
• Strong familiarity with FDA, EMA, and ICH guidelines for regulatory submissions.
• Excellent written and verbal communication and cross-functional collaboration.
• Ability to interpret regulatory requirements and advise development teams.

Responsibilities

• Design and implement CMC regulatory control strategies across product lifecycle.
• Author and review sections of CTAs, INDs/NDAs/MAAs, and post-approval variations.
• Respond to health authority queries and information requests.
• Prepare and maintain quality risk assessments (ICH M7, ICH Q3D, nitrosamines).
• Advise teams on starting materials, specifications, and manufacturing processes.
• Interface with Regulatory Affairs, Supply Chain, and technical teams on global filing strategies.

Skills

Regulatory strategy

Regulatory writing

FDA/EMA/ICH knowledge

Project leadership

Education

PhD with 7+ years

BS/MS with 10+ years

Job description

BridgeBio is seeking a Senior Manager/Associate Director for CMC Regulatory Sciences. You will lead cross-functional regulatory activities across Drug Substance, Drug Product, and Analytical Development, authoring sections for global applications and guiding responses to health authorities.

The role emphasizes interaction with international regulatory teams, development partners, and compliance with ICH and FDA/EMA guidelines, while leveraging AI tools to improve submissions and data governance.