Senior Regulatory Domain Expert - Falcon

• 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.