Senior Manager – Regulatory Affairs

BridgeBio

. Develop and execute regional regulatory strategies for development programs .

Posted 11/5/2026full-timeRemote • United StatesSenior💰 $160,000 - $225,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing regulatory strategies for drug development, including IND and NDA submissions, while maintaining compliance with US and international regulations. Proficient in collaborating with cross-functional teams and managing regulatory submissions and timelines effectively.

Highest-signal resume keywords

Regulatory Affairs ExperienceIND Submission ExpertiseKnowledge of FDA RegulationsECTD Submission ProficiencyCollaboration with CROs

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Document SubmissionDrug Development Process KnowledgeCompliance with ICH and GCPRegulatory Submission Timeline Management

Soft Skills

Interpersonal CommunicationProblem SolvingAttention to DetailOrganizational SkillsStrategic Guidance

Tools & Technologies

Microsoft OfficeVeeva Electronic Document Management Systems

Industry Keywords

Pharmaceutical Industry21 CFRGMPEMAClinical Trial Activations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop and execute regional regulatory strategies for development programs
Provide regional regulatory guidance and oversight for product development and registration strategies, including nonclinical and clinical development
Plan, compile, review, and submit regulatory documents, including initial INDs, CTAs, NDAs, amendments, and supplements
Represent Regulatory at cross-functional team meetings
Lead study-related regulatory activities and provide strategic guidance on study-level decisions
Own global study-level regulatory activities, including CTA and IND submissions, investigator document package reviews and approvals, and FDA submissions
Track regulatory and ethics submissions and approvals across studies
Facilitate FDA and other Health Authority meetings with Regulatory leadership
Collaborate with project teams to plan, review, finalize, and sign off regulatory submissions
Develop, maintain, and communicate regulatory submission timelines
Review protocols, ICFs, IBs, CSRs, and DSURs for compliance with ICH, FDA, EMA, and other applicable regulations
Coordinate with CROs and vendors to plan and finalize health authority submissions
Manage regulatory agency queries and commitments, coordinate written responses with subject matter experts, and provide status updates
Contribute to global regulatory submissions and strategic planning
Maintain regulatory databases, submission logs, and correspondence logs
Review, write, and present regulatory guidelines and SOPs
Maintain current knowledge of US and global regulations, guidance, and standards for drug development and product registration

Requirements

What you’ll need

BA/BS degree in the biological or physical sciences; advanced degree (e.g., PharmD or PhD) preferred
Relevant pharmaceutical industry experience, including regulatory affairs experience
Minimum of 3 years of industry experience generally required for the Senior Manager level; greater experience and scope expected at the Associate Director level
An equivalent combination of education and experience may be considered
Knowledge of US FDA and international pharmaceutical guidance and regulations, including 21 CFR, ICH, GCP, GMP, and EMA
Knowledge of the drug development process and industry-standard practices
Demonstrated experience supporting eCTD-formatted submissions, including INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements
Experience coordinating or supporting responses to health authorities or other critical submission projects while maintaining agreed timelines
Proficient written, oral, and interpersonal communication in English
Ability to collaborate with regulatory colleagues and throughout the development organization
Capability to provide strategic guidance on regulatory and program-related issues
Ability to problem solve unexpected problems or roadblocks
High attention to detail; ability to organize, prioritize, and delegate assigned projects
Experience interacting with CROs in managing US eCTD IND submissions and ex-US CTAs toward clinical trial activations preferred
Proficient user of Microsoft Office (Word, Excel, PowerPoint)
Experience using Veeva electronic document management systems and document review tools

Benefits

Comp & perks

Market-leading compensation
Annual performance bonus
Company equity
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