Remote Regulatory Lead (Sr. Manager/AD)

Regulatory Jobs; United States; Remote; USD 160,000 - 225,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program

Job summary

BridgeBio is seeking a senior Regulatory Affairs leader to develop and execute global regulatory strategies for efficient development programs. The role involves cross-functional collaboration, leading regional submissions, and ensuring compliance with US FDA and international guidelines.

Remote US-based with travel to SF/Palo Alto as needed. The ideal candidate has 3+ years in regulatory affairs, strong experience with eCTD submissions, and excellent communication skills in English.

Qualifications

• Deep knowledge of US FDA guidance (ICH, GXP)
• Experience with eCTD submissions (INDs/NDAs/CTAs)
• Ability to lead regulatory strategy across development programs

Responsibilities

• Develop and execute regional regulatory strategies for development programs.
• Plan and submit regulatory documents (INDs/CTAs/NDAs) with oversight.
• Lead study-related regulatory activities and liaise with CROs and health authorities.

Skills

Regulatory strategy

IND/CTA/NDA submissions

US FDA regulations

Cross-functional leadership

Written and verbal communication

Education

BA/BS in sciences

Advanced degree preferred

Tools

Veeva

MS Office

Job description

BridgeBio is seeking a senior Regulatory Affairs leader to develop and execute global regulatory strategies for efficient development programs. The role involves cross-functional collaboration, leading regional submissions, and ensuring compliance with US FDA and international guidelines.

Remote US-based with travel to SF/Palo Alto as needed. The ideal candidate has 3+ years in regulatory affairs, strong experience with eCTD submissions, and excellent communication skills in English.