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Witt O'Brien's

Regulatory Specialist

Houston, TX · On-site

... temporary in-plant positions. * Prepare project documentation, business presentations, and ... on operational needs. Commitment to Diversity Witt O'Brien's is always looking for the most ...

Actalent

Regulatory Coordinator

Northbrook, IL

$24 - $28.85/hr

Collaborate with cross-functional teams such as R&D, Quality, and Operations to address regulatory ... If eligible, the benefits available for this temporary role may include the following: • Medical ...

Witt O'Brien's

Regulatory Specialist

Houston, TX · On-site

... temporary in-plant positions. * Prepare project documentation, business presentations, and ... on operational needs. Commitment to Diversity Witt O'Brien's is always looking for the most ...

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Regulatory Business Analyst - Regulatory Technology (Contract)

Regulatory Business Analyst - Regulatory Technology (Contract)

Vertex Pharmaceuticals Incorporated

Remote

$75/hr

Full-time

Posted 16 days ago

Job description

Job Description
We are looking for an experienced Regulatory Business Analyst with strong expertise in Veeva Vault RIM, regulatory data management, and business process optimization to support Global Regulatory Affairs technology initiatives. The ideal candidate will have experience gathering and translating business requirements, supporting system enhancements and integrations, driving user acceptance testing and change management activities, and partnering with cross-functional stakeholders to improve regulatory operations. Experience with Veeva Vault RIM data models, IDMP/PMS standards, eCTD publishing, reporting and analytics, and emerging technologies such as AI and automation is highly desirable. The successful candidate will be a proactive, self-directed professional who can independently drive initiatives while serving as a trusted partner between Regulatory Affairs and technical teams.
Required Knowledge & Skills
  • Elicit, document, and translate business requirements into system enhancements for Veeva Vault RIM, and other systems, working closely with regulatory stakeholders, superusers, and IT teams.
  • Serve as a functional SME for Veeva Vault RIM, with strong understanding of the data model, including registration objects and core regulatory data structures.
  • Support design, enhancement, and ongoing optimization of Veeva Vault RIM, including integrations with Veeva Quality, Clinical, and PromoMats.
  • Apply working knowledge of IDMP data models (including PMS) to support data remediation efforts and ensure accurate representation of regulatory data within Vault RIM.
  • Configure and support key RIM capabilities, including Global Content Plans, Active Dossier setup, and dossier management across Modules 2-5.
  • Partner with technical teams to support system design, validation, data migration, data cleansing, and UAT activities, including test script review.
  • Develop and maintain reports and dashboards across Vault RIM objects to enable KPI tracking, data monitoring, and informed business decision-making.
  • Collaborate cross-functionally to prioritize enhancements, drive process optimization, and ensure alignment between business needs and system capabilities.
  • Support user education and change management, including development of training materials, business guidelines, and reference documentation.
  • Communicate effectively with stakeholders at all levels; work independently and proactively to drive initiatives forward.
  • Contribute to broader regulatory technology strategy, including adoption of modernization approaches (e.g., AI-enabled authoring tools, labeling/CMC modernization, ICH M4Q(R2), FHIR-based standards).
  • Support capabilities related to eCTD submissions, including experience with or exposure to eCTD 4.0 within Vault RIM environments (preferred).

Required Experience & Education
  • B.S. degree (or equivalent experience) with 5+ years of experience in regulatory operations, regulatory technology, or business analysis.
  • Proven experience with Veeva Vault RIM including configuration, data model understanding, and business process support.
  • Experience with regulatory data standards (e.g., IDMP/PMS) and their application in system implementations or data remediation efforts.
  • Experience with system integrations within the Veeva ecosystem (e.g., RIM-Quality).
  • Hands-on experience with requirements gathering, documentation, and translation into system enhancements.
  • Experience supporting validation processes, including UAT coordination, test script review.
  • Experience creating training materials, SOPs, and user documentation, and supporting adoption of new capabilities post-go-live.
  • Experience with reporting and analytics within enterprise systems to support KPIs and operational metrics.
  • Familiarity with eCTD publishing solutions; exposure to eCTD 4.0 is a plus.
  • Exposure to AI/GenAI tools, automation, or digital transformation initiatives in regulatory or content processes is a plus.

Contract Length: 6 months with the chance to extend.
Pay Range
75/hr. - 82/hr.
Shift/Hours
Monday - Friday; Remote
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals ("Vertex"). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex's Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
(collectively, "Atrium Alerts"). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at privacyadministrator@atriumstaff.com.
If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at tempstaffing@vrtx.com. Please include the job title in the subject of your email.
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