Senior Manager/Associate Director, Regulatory Affairs

BridgeBio Pharma

5d•$160,000 - $225,000•Remote

About The Position

BridgeBio is seeking a talented and motivated regulatory affairs leader to develop and execute regulatory strategies that support efficient development pathways. The role collaborates with cross-functional project teams to plan development strategies and leads global regulatory submissions for assigned projects. The candidate is expected to work independently or with limited oversight, apply knowledge of regulatory requirements and guidelines to daily work, and manage critical projects as part of an interdisciplinary team. Level—Senior Manager or Associate Director—will be determined by experience and scope of responsibility. This is a U.S.-based remote role requiring occasional, as-needed travel to BridgeBio’s San Francisco or Palo Alto offices. The anticipated California salary range is $160,000–$225,000 USD. The final offer may depend on experience, education, location, and interview performance, and the stated range may not apply to positions based in other states.

Requirements

BA/BS degree in biological or physical sciences; an equivalent combination of education and experience may be considered.
Relevant pharmaceutical industry experience, including regulatory affairs experience. A minimum of 3 years of industry experience is generally required for the Senior Manager level; greater experience and scope of responsibility are expected at the Associate Director level.
Knowledge of U.S. FDA and international pharmaceutical guidance and regulations, including 21 CFR, ICH, GCP, GMP, and EMA requirements, as well as the drug development process and industry-standard practices.
Demonstrated experience supporting eCTD-formatted submissions, such as INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements.
Experience coordinating or supporting responses to health authorities or other critical submission projects while meeting agreed timelines.
Proficient written, oral, and interpersonal communication skills in English.
Ability to collaborate closely with colleagues in Regulatory and throughout the development organization.
Ability to provide strategic guidance on regulatory and program-related issues.
Ability to solve unexpected problems or roadblocks.
Strong attention to detail and ability to organize, prioritize, and delegate assigned projects.
Proficiency with the standard MS Office suite, including Word, Excel, and PowerPoint.
Ability to work remotely from within the United States and travel occasionally, as needed, to the San Francisco or Palo Alto offices.

Nice To Haves

Advanced degree, such as a PharmD or PhD.
Experience interacting with CROs to manage U.S. eCTD IND submissions and ex-U.S. CTAs toward clinical trial activations.
Experience using Veeva electronic document management systems and document review tools.

Responsibilities

Develop and execute regional regulatory strategies for development programs, including regulatory guidance for product development and registration and oversight of nonclinical and clinical development.
Plan, compile, review, and submit regulatory documents, including initial INDs, CTAs, NDAs, amendments, and supplements, independently or with limited oversight.
Represent Regulatory at cross-functional team meetings and provide strategic regulatory guidance for study-level decisions.
Keep study teams informed about regulatory activities and own study-level global regulatory activities, including CTA and IND submissions, investigator document package reviews and approvals, associated FDA submissions, and other study regulatory matters.
Manage tracking of regulatory and ethics submissions and approvals across studies.
Facilitate FDA and other Health Authority meetings in collaboration with Regulatory leadership.
Collaborate with Project Team representatives to plan regulatory documents and support their review, finalization, and sign-off.
Develop, maintain, and communicate regulatory submission timelines to support timely delivery of documentation.
Review critical documents such as protocols, ICFs, IBs, CSRs, and DSURs for compliance with applicable regulations and guidance before submission.
Coordinate with CROs and other vendors to plan and finalize submissions to health authorities.
Manage and track regulatory agency queries and commitments, collaborate with subject matter experts on written responses, and provide status updates on unfulfilled conditions and commitments.
Contribute to global regulatory submissions and strategic planning as applicable.
Help maintain regulatory databases, including submission and correspondence logs.
Review, write, and present regulatory guidelines and SOPs as needed to support high-quality submissions and compliance.
Maintain current knowledge of applicable U.S. and global regulations, guidance, and standards for drug development and product registration.

Benefits

Market-leading compensation, an annual performance bonus, and company equity.
401(k) with employer match.
Employee Stock Purchase Program (ESPP).
Pre-tax commuter benefits for 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 employees and dependents.
Health Savings Account with annual employer contributions and Flexible Spending Accounts.
Fertility and family-forming benefits.
Expanded mental health support, including 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, continuous education, and professional development programs, including LinkedIn Learning, LifeLabs, and BetterUp Coaching.
Career pathing, regular feedback, and internal mobility opportunities.
Financial rewards, peer-to-peer recognition, and growth opportunities for strong performance.