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Viatris

R&D and Regulatory Systems Lead

Viatris

. Work with Regulatory Affairs and other R&D functions to understand technology needs and ensure global processes and systems are compliant and representative of cross-functional needs .

Posted 9/23/2026full-timeRemote • United StatesSenior💰 $95,000 - $193,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in Regulatory Affairs and R&D processes, with a strong focus on Veeva RIM Vault administration, system integrations, and compliance with global health authority requirements. Proven ability to manage complex projects, translate business needs into technical requirements, and ensure adherence to regulatory standards.

Highest-signal resume keywords
Veeva RIM Vault AdministrationRegulatory Business Process KnowledgeSoftware Design and DevelopmentProject Management MethodologiesGxP Compliance Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Veeva RIM Vault ConfigurationSystem IntegrationJava ProgrammingPython ProgrammingAnalytics Report BuildingData Flow AnalysisRequirements GatheringProcess ModelingPrototypingRoot Cause Analysis
Soft Skills
Excellent Communication SkillsAttention to DetailProblem-Solving AbilityCollaboration SkillsAbility to Manage Multiple Priorities
Tools & Technologies
Power BISaaS SolutionsAI AgentsChange Management ToolsIT Quality Processes
Certifications & Qualifications
Veeva RIM Vault CertificationVeeva Certification
Industry Keywords
Pharmaceutical IndustryRegulatory Compliance StandardsGCP RegulationsEMA RegulationsFDA Regulations

Tech Stack

Tools & technologies
Google Cloud PlatformJavaPythonSDLCVault

About the role

Key responsibilities & impact
  • Work with Regulatory Affairs and other R&D functions to understand technology needs and ensure global processes and systems are compliant and representative of cross-functional needs
  • Provide strong working knowledge of digital capabilities supporting global R&D business processes
  • Monitor emerging global health authority requirements and assess system impact
  • Develop and implement requirements to ensure compliance
  • Collaborate with business users to identify needs and translate them into functional and technical requirements
  • Perform requirements gathering, process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis
  • Administer and develop Veeva RIM Vault, including package software, application implementation, and Vault API integrations
  • Lead administration, enhancements, fixes, configurations, and regular deployment of RIM Vaults
  • Lead technical design and enhance integrations between systems
  • Design, architect, and lead development of complex applications
  • Manage assigned projects through implementation within scope, schedule, and budget
  • Work globally on end-to-end R&D solution implementations and regulatory compliance
  • Drive compliance with IT Quality and Viatris SDLC, change management, and quality/testing processes
  • Collaborate with solutions leads and business partners to ensure technology meets business requirements
  • Support vendor relationships and escalate system issues

Requirements

What you’ll need
  • Bachelor's degree in science, IT, or a relatable field
  • 10 years’ of Regulatory business process knowledge and strong hands-on technical experiences configuring, migrating and integrating Veeva RIM Vaults and other R&D solutions required
  • 10 years’ hands on experience with software design and development, system integrations, analytics report builds required
  • Prior experience in the pharmaceutical industry and a solid understanding of R&D & Regulatory business processes
  • Experience with validated GxP environments, including Implementation, documentation, and change management is necessary
  • Hands on experience implementing, configuring, migrating and integrating Veeva Vault RIM platform including Registrations, Submissions & Archive Vaults (Required)
  • Broad technical knowledge, including hands on experience designing and implementing system integrations as well as working with migrations and SaaS in a regulated environment
  • Hands on experience designing and building solutions with Java, python, creating AI agents and working with analytics tools including building Power BI reports
  • Proven track record of defining technology strategy aligned with business objectives
  • Previous experience as IT system owner supporting R&D
  • Experience in business processes for regulatory submission planning and tracking, registration management, commitment management and content management
  • Knowledge of GCP, EMA + FDA regulations and other regulatory compliance standards
  • Experience with project management methodologies such as Agile, Waterfall, and Hybrid approaches
  • Strong analysis and project management skills as well as attention to detail
  • Ability to challenge requirements with key stakeholders to ensure requirements are detailed and properly defined
  • Ability to solve highly complex enterprise-wide technical challenges
  • Ability to operate in a dynamic challenging environment and manage multiple activities, priorities, and deadlines.
  • Excellent verbal and written communication skills
  • Works well in and appreciates the value of a global diverse work environment.
  • Is able to see the larger picture and able to identify and successfully communicate key issues in complex situations.
  • Veeva RIM Vault certification preferred; Veeva certification desired
  • Advanced degrees are a plus

Benefits

Comp & perks
  • Competitive salaries
  • Remote flexibility
  • Inclusive environment
  • Equal opportunity employment