Remote Regulatory Affairs Leader: Global Submissions

BridgeBio Inc.; United States; Remote; USD 160,000 - 225,000; Full time

Benefits offered by this job

Health insurance

Employee Stock Purchase Program (ESPP)

401(k) with employer match

Hybrid work model

Pre-tax commuter benefits

Job summary

BridgeBio Inc. is seeking a regulatory affairs leader to develop and execute regulatory strategies for development programs. The role involves leading global submissions, cross-functional collaboration, and strategic guidance on regulatory decisions.

The candidate will coordinate with study teams, CROs, and regulatory authorities, ensuring timely submissions and adherence to FDA/ICH guidelines. The role offers a remote, U.S.-based arrangement with periodic travel to San Francisco or Palo Alto,

Qualifications

• BA/BS in biological or physical sciences required.
• Experience with regulatory affairs in pharma or biotech industry.

Responsibilities

• Develop and execute regional regulatory strategies for development programs.
• Plan, compile, review, and submit regulatory documents (INDs/CTAs/NDAs).
• Represent Regulatory at cross-functional team meetings.
• Coordinate with CROs and internal teams on regulatory submissions and timelines.
• Maintain knowledge of US and global regulations (ICH, FDA, EMA).

Skills

Regulatory strategy

eCTD submissions

FDA/EMA knowledge

Cross-functional leadership

Project management

English communication

Education

BA/BS in biological or physical sciences

Advanced degree (PharmD/PhD) preferred

Tools

Veeva

MS Office

Job description

BridgeBio Inc. is seeking a regulatory affairs leader to develop and execute regulatory strategies for development programs. The role involves leading global submissions, cross-functional collaboration, and strategic guidance on regulatory decisions.

The candidate will coordinate with study teams, CROs, and regulatory authorities, ensuring timely submissions and adherence to FDA/ICH guidelines. The role offers a remote, U.S.-based arrangement with periodic travel to San Francisco or Palo Alto,