Senior Regulatory Domain Expert - Falcon

 

 

 

We are seeking an experienced regulatory operations professional to serve as our Senior Regulatory Domain Expert for Veeva Falcon. If you are a process-driven optimizer who is frustrated by the manual data-entry, repetitive checking, and data-chasing inherent in traditional Regulatory Information Management (RIM), this is your opportunity to help design a tech-forward solution. You will bring your deep knowledge of global submission lifecycles and health authority data standards to bear, advising our product and engineering teams as they build next-generation automation tools. Actively partnering with early adopter companies, you will serve as the definitive "Voice of the Customer" to replace legacy manual processes with intelligent digital labor.

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

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

Prior experience contributing to system configurations, data migrations, or user-acceptance testing (UAT) for enterprise regulatory software deployments

We value your time and believe in a transparent hiring process. Here is the process you can expect.

Follow the application process and submit your resume.

Within 3 days, you will receive a link to a personality assessment administered by a third party, unless you have already completed it with Veeva previously.

Once you complete the assessment, our team will review your full application package and follow up via email with our decision.

If moving to the interview stage, the process is as follows:

1. A conversation with the hiring manager
2. A practical case exercise
3. A final conversation with our group's Senior Leader.

Once all interviews are complete, the manager will be in touch with a final decision.