Associate Director, Regulatory Affairs – CMC

BridgeBio

. Develop global CMC regulatory strategies with the manager and CMC subject-matter experts for the Eidos program .

Posted 9/23/2026full-timeUnited StatesSenior💰 $190,000 - $235,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing global CMC regulatory strategies and managing cross-functional collaboration for regulatory submissions. Proficient in project management, regulatory compliance, and leveraging technology to enhance efficiency in drug development processes.

Highest-signal resume keywords

CMC Regulatory Strategy DevelopmentCross-Functional CollaborationProject ManagementRegulatory Affairs ExperienceKnowledge of Global Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsCMC AuthoringDrug DevelopmentQuality ControlQuality AssuranceRegulatory Dossier PreparationHealth Authority InteractionRegulatory Strategy RecommendationsDocument Management SystemsArtificial Intelligence Tools

Soft Skills

Excellent Communication SkillsAttention to DetailInterpersonal SkillsActive ListeningInfluencing Skills

Tools & Technologies

Microsoft SuiteVeeva

Industry Keywords

Pharmaceutical IndustryDrug RegistrationGlobal RegulationsRegulatory GuidanceInterdisciplinary Teams

About the role

Key responsibilities & impact

Develop global CMC regulatory strategies with the manager and CMC subject-matter experts for the Eidos program
Collaborate with cross-functional teams, including Regulatory International, to create and prepare CMC sections of global regulatory dossiers and marketing applications
Help prepare and communicate timelines
Plan and coordinate preparation of CMC sections
Manage authoring, review, and approval workflows
Provide regulatory strategy recommendations to the team
Support Health Authority interactions, including coordinating meeting requests and briefing books
Work with the team on strategy and responses to Health Authority CMC questions
Support regulatory responses from triage through finalization
Maintain current knowledge of global regulations, guidance, and standards for drug development and product registration
Represent Regulatory Affairs CMC on interdisciplinary teams as needed
Perform other duties as assigned
Report to the Senior Director, Regulatory Affairs CMC

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, e.g., drug development/manufacturing/QC/QA (an equivalent combination of education and experience may be considered)
Excellent communication skills and attention to detail
Ability to independently manage projects and deliver output in a timely manner with limited manager direction
Excellent computer skills, including Microsoft Suite applications/software and document management systems such as Veeva
Self-starter able to take initiative, work independently, and proactively identify and execute tasks with minimal supervision
Excellent interpersonal, active listening, and influencing skills
Ability to leverage artificial intelligence tools to support and enhance complex tasks, improving efficiency and decision-making quality
U.S.-based work authorization/location requirement

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
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
Skill development and internal mobility opportunities
Career pathing through regular feedback, continuous education, and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
Financial rewards, peer-to-peer recognition, and growth opportunities
Annual performance bonus
Company equity
Generous health benefits