Senior Regulatory Domain Expert - Falcon

Veeva Systems•Massachusetts - Boston, MA

3d•Remote

About The Position

Veeva Systems is seeking an experienced regulatory operations professional to serve as Senior Regulatory Domain Expert for Veeva Falcon. The role advises product and engineering teams as they develop next-generation automation tools for Regulatory Information Management (RIM), using deep knowledge of global submission lifecycles and health authority data standards. The expert will partner with early adopter companies and represent the customer perspective, helping replace manual regulatory processes with intelligent digital labor. The position involves guiding product and engineering teams on regulatory workflows, reviewing platform outputs for accuracy and submission readiness, and developing real-world scenarios and edge cases to test and improve platform performance. Veeva is a Work Anywhere company, supporting work from home or an office. The position offers a base salary range of $120,000–$180,000 and may also be eligible for variable bonus and/or stock bonus.

Requirements

At least 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, including IND, NDA, BLA, and MAA.
Experience with eCTD publishing standards.
Strong working knowledge of data maintenance requirements in mainstream RIM systems, such as Veeva Vault.
Exceptional communication and presentation skills, including the ability to translate complex regulatory requirements into actionable guidance for non-regulatory stakeholders.
Passion for learning about agentic AI and an adaptive mindset toward automation’s potential to transform regulatory data compliance.

Nice To Haves

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

Responsibilities

Advise product and engineering teams on operational workflows for global regulatory planning, dossier compilation, and health authority data standards, including IDMP and SPOR.
Review, test, and provide expert feedback on platform outputs, including automated metadata tagging, health authority data mapping, and submission-readiness tracking.
Build a library of real-world regulatory scenarios, complex global submission sequences, and data edge cases to test and refine platform performance.
Partner with early adopter companies and represent the customer perspective in the development of automation tools.