R&D and Regulatory Systems Lead

🕒 September 23

🇺🇸 United States – Remote

💵 $95k - $193k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Viatris

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2020

🏥 Healthcare

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Healthcare • Pharmaceuticals • Healthcare Insurance

Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

📋 Description

• Work with Regulatory Affairs and other R&D functions to understand technology needs and ensure global processes and systems are compliant • Provide 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 • Gather requirements using process modeling, interviews, user stories, prototyping, data flows, and root cause analysis • Administer and develop Veeva RIM Vaults, including package software, application implementation, and Vault API integrations • Lead Vault administration, enhancements, fixes, configurations, and code migrations • Lead technical design for assigned projects and enhance system integrations • Design, architect, and lead development of complex applications • Manage projects through implementation, ensuring delivery within scope, schedule, and budget • Work with global teams to implement R&D solutions and ensure compliance with FDA, EMA, and other health agency regulations • Drive compliance with IT Quality and Viatris SDLC processes, including change management and testing • Collaborate with solution leads and business partners to ensure technologies meet business requirements • Support vendor relationships and escalate system issues promptly

🎯 Requirements

• Bachelor's degree in science, IT, or a related field • 10 years of Regulatory business process knowledge and strong hands-on technical experience configuring, migrating, and integrating Veeva RIM Vaults and other R&D solutions • 10 years of hands-on experience with software design and development, system integrations, and analytics report builds • Prior experience in the pharmaceutical industry and understanding of R&D and Regulatory business processes • Experience with validated GxP environments, including implementation, documentation, and change management • Hands-on experience implementing, configuring, migrating, and integrating the Veeva Vault RIM platform, including Registrations, Submissions, and Archive Vaults • Broad technical knowledge of system integrations, migrations, and SaaS in a regulated environment • Hands-on experience with Java, Python, AI agents, and analytics tools including Power BI reports • Proven track record defining technology strategy aligned with business objectives • Previous experience as an IT system owner supporting R&D • Experience with 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 Agile, Waterfall, and Hybrid project management methodologies • Strong analysis, project management, communication, and attention-to-detail skills • Ability to challenge and properly define requirements with stakeholders • Ability to solve complex enterprise-wide technical challenges • Ability to manage multiple activities, priorities, and deadlines in a dynamic environment • Ability to work effectively in a global, diverse work environment • Ability to identify and communicate key issues in complex situations • Veeva RIM Vault certification preferred; Veeva certification desired

🏖️ Benefits

• Competitive salaries • Inclusive environment • Remote flexibility