Remote Associate Director, Regulatory Affairs CMC

Regulatory Jobs; United States; Remote; USD 190,000 - 285,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Hybrid work model

Paid time off and holidays

Comprehensive medical, dental, and VSP

Job summary

BridgeBio is seeking an Associate Director/Director of Regulatory Affairs CMC in a US-based role with remote work and periodic visits to San Francisco. The position requires directing global CMC regulatory strategies, coordinating cross-functional teams, and managing regulatory submissions across ROW. Strong QMS, regulatory knowledge, and AI-enabled efficiency are valued for advancing lifecycles and patient access.

Qualifications

• Bachelor’s degree in life sciences (preferred)
• 7+ years in pharmaceutical regulatory affairs, CMC or related function
• Excellent communication and attention to detail
• Independently manage projects and deliver output with limited supervision
• Strong computer skills (Microsoft Office, Veeva)
• Experience leveraging AI tools to support regulatory tasks

Responsibilities

• Develop global CMC regulatory strategies with manager and CMC SMEs to meet business objectives for the program
• Collaborate with cross-functional teams to create and prepare CMC sections of regulatory dossiers (ROW)
• Plan and coordinate preparation of CMC sections; manage authoring, review and approval workflows
• Provide RA CMC support for Health Authority interactions and responses
• Maintain knowledge of applicable global regulations and standards for drug development and product registration
• Other duties as assigned.

Skills

Excellent communication

Independent project management

Attention to detail

Interpersonal influence

AI-enabled regulatory tasks

Education

Bachelor's degree in life sciences

Tools

Veeva

Microsoft Office

Job description

BridgeBio is seeking an Associate Director/Director of Regulatory Affairs CMC in a US-based role with remote work and periodic visits to San Francisco. The position requires directing global CMC regulatory strategies, coordinating cross-functional teams, and managing regulatory submissions across ROW. Strong QMS, regulatory knowledge, and AI-enabled efficiency are valued for advancing lifecycles and patient access.