Senior Regulatory Domain Expert - Falcon

Veeva Systems; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, vision, and basicLife

Flexible PTO and holidays

Retirement programs

1% charitable giving

Job summary

Veeva Systems is seeking an experienced Regulatory Domain Expert for Veeva Falcon to advance automated regulatory information management. You will apply deep knowledge of global submission lifecycles and health authority standards to guide product and engineering teams, acting as the Voice of the Customer for front-line automation initiatives.

You will partner with early adopter clients, review outputs, validate metadata tagging, and help design scalable workflows that reduce manual data-chasing

Qualifications

• 7+ years of active experience in Regulatory Affairs or Regulatory Information Management (RIM) within pharma/biotech/CRO
• Deep knowledge of global regulatory submission lifecycles (IND, NDA, BLA, MAA) and eCTD
• Strong ability to translate regulatory needs for non-regulatory stakeholders
• Interest in agentic AI and automation for regulatory data compliance

Responsibilities

• Guide product and engineering teams on regulatory planning and data standards (IDMP, SPOR)
• Review and provide feedback on platform outputs to ensure regulatory accuracy
• Create diverse real-world regulatory scenarios to test platform performance

Skills

RIM experience

Regulatory Affairs

Global submissions

Veeva Vault knowledge

Communication skills

AI interest

Tools

Veeva Vault

Job description

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead.

At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation, legally bound to balancing the interests of customers, employees, society, and investors.

As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

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.

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

Perks & Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program

Compensation

• Base pay: $120,000 - $180,000
• The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus.

Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [e-mail].