Remote Senior Regulatory Domain Expert – RIM & Automation

Veeva Systems; San Francisco (CA); Remote; USD 180,000 - 240,000; Full time

Job summary

Veeva Systems in San Francisco seeks an experienced Senior Regulatory Domain Expert for Veeva Falcon to optimize regulatory information management through automation and AI. You will advise product and engineering on global submission lifecycles (IND/NDA/BLA/MAA), harness IDMP/SPOR standards, and partner with early adopters to replace manual workflows with digital solutions.

The role emphasizes collaboration, strong communication, and a passion for learning about agentic AI, with flexible work

Qualifications

• 7+ years of active experience in Regulatory Affairs or Regulatory Information Management (RIM) within a pharma, biotech, or CRO environment.
• Deep operational familiarity with global regulatory submission lifecycles (IND, NDA, BLA, MAA) and eCTD publishing standards.
• Strong, working knowledge of data maintenance requirements within mainstream RIM systems (e.g., Veeva Vault).
• Exceptional communication and presentation skills, with a track record of translating complex regulatory requirements into actionable guidance for non-regulatory stakeholders.
• A passion for learning about agentic AI and an adaptive mindset regarding how automation can transform regulatory data compliance.

Responsibilities

• Product Advisory & Workflow Guidance: Guide product and engineering teams on the real-world operational nuances of global regulatory planning, dossier compilation, and the complexities of health authority data standards (e.g., IDMP, SPOR)
• Output Verification & Quality Gatekeeping: Actively review, test, and provide expert feedback on platform outputs- verifying automated metadata tagging, health authority data mapping, and submission readiness tracking to ensure zero regulatory discrepancies
• Stress-Test Scenario Curation: Build a comprehensive library of real-world regulatory scenarios, complex global submission sequences, and data edge cases to challenge and refine platform performance

Skills

Regulatory Affairs

RIM

Global submission lifecycles

eCTD

AI in regulatory

Tools

Veeva Vault

Job description

Veeva Systems in San Francisco seeks an experienced Senior Regulatory Domain Expert for Veeva Falcon to optimize regulatory information management through automation and AI. You will advise product and engineering on global submission lifecycles (IND/NDA/BLA/MAA), harness IDMP/SPOR standards, and partner with early adopters to replace manual workflows with digital solutions.

The role emphasizes collaboration, strong communication, and a passion for learning about agentic AI, with flexible work