Remote Regulatory Affairs Leader (Senior Manager/AD)

BridgeBio Pharma; 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 (ESPP)

Pre-tax commuter benefits

Referral bonus for hired candidates

Subsidized lunch and parking on in‑off

100% employer-paid medical, dental, &

Job summary

BridgeBio Pharma is seeking a Senior Manager/Associate Director of Regulatory Affairs for a remote US-based role. You will lead regulatory strategies, submissions (INDs/CTAs/NDAs), and global health authority interactions, with a focus on efficient development pathways and cross-functional collaboration.

Competitive salary falls within a broad US range to reflect experience. The role requires strong knowledge of US FDA regulations, ICH guidelines, and eCTD processes, plus ability to guide senior

Qualifications

• Experience in regulatory affairs within pharma/biotech.
• Familiar with US FDA guidelines, ICH, GMP, GMP.
• Experience supporting eCTD submissions (INDs/NDAs/BLAs).

Responsibilities

• Develop and execute regulatory strategies for development programs.
• Plan, compile, review, and submit regulatory documents (INDs/CTAs/NDAs).
• Lead regulatory submissions and interact with health authorities.
• Coordinate with CROs and internal teams for submissions.
• Maintain timelines and regulatory databases; draft SOPs as needed.

Skills

Regulatory strategy

IND/CTA submissions

US FDA guidance

eCTD submissions

Cross-functional collaboration

Regulatory project management

Education

BA/BS in biological or physical sciences

Advanced degree preferred (PharmD/PhD)

Tools

Veeva

MS Office (Word/Excel/PowerPoint)

Job description

BridgeBio Pharma is seeking a Senior Manager/Associate Director of Regulatory Affairs for a remote US-based role. You will lead regulatory strategies, submissions (INDs/CTAs/NDAs), and global health authority interactions, with a focus on efficient development pathways and cross-functional collaboration.

Competitive salary falls within a broad US range to reflect experience. The role requires strong knowledge of US FDA regulations, ICH guidelines, and eCTD processes, plus ability to guide senior