Associate Director, Regulatory Affairs – CMC

BridgeBio

Associate Director overseeing global CMC regulatory strategies at BridgeBio Pharma. Collaborating with diverse teams to ensure compliance and communication with health authorities while managing projects.

Posted 5/13/2026full-timeCalifornia • 🇺🇸 United StatesSenior💰 $190,000 - $235,000 per yearWebsite

About the role

Key responsibilities & impact

Develop global CMC regulatory strategies in collaboration with manager and CMC subject-matter experts to meet business objectives for the Eidos program
Collaborate with cross-functional teams (e.g. Regulatory Int.) to create and prepare CMC sections of regulatory dossiers marketing applications (ROW)
Help prepare and communicate timelines
Plan and coordinate preparation of the CMC sections
Manage the author, review and approval workflows
Provide recommendations to team on regulatory strategy as needed
Provide RA CMC support for Health Authority interactions, including coordination of drafting and reviewing meeting requests and briefing books.
Work with team on strategy and responses to Health Authority CMC questions (ROW)
Provide support from triage through finalization of regulatory responses
Maintain current knowledge of applicable global regulations, guidance and standards for drug development and product registration
Other duties as assigned.

Requirements

What you’ll need

A minimum of a bachelor’s degree is required (life sciences discipline preferred)
Minimum of 7 years experience in pharmaceutical or related industry in regulatory affairs, CMC or related function, eg, drug development/manufacturing/QC/QA (an equivalent combination of education and experience may be considered)
Excellent communication skills and attention to detail
Independently able to manage projects and deliver output in a timely manner with limited direction of manager
Excellent computer skills, e.g., Microsoft suite of applications/software and document management system such as Veeva
Demonstrated self-starter with the ability to take initiative, work independently, and proactively identify and execute tasks with minimal supervision.
Excellent interpersonal, active listening, and influencing skills
Demonstrated ability to leverage artificial intelligence tools to support and enhance the execution of complex tasks, improving efficiency, and decision-making quality.

Benefits

Comp & perks

Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyCMC sections preparationregulatory dossiersdrug developmentmanufacturingquality controlquality assuranceproject managementregulatory responsesglobal regulations

Soft Skills

communication skillsattention to detailindependent project managementinitiativeproactive task executioninterpersonal skillsactive listeninginfluencing skillsself-startertimely delivery