Senior Regulatory Domain Expert - Falcon

Description

The Role

What You'll Do

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

Requirements

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

Nice to Have

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

Interviewing with Veeva

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.

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