R&D and Regulatory Systems Manager

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $78k - $152k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 0%

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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 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, interviewing, 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 RIM Vault administration, enhancements, fixes, configurations, and code migrations • Provide technical design for projects and improve system integrations • Manage projects through implementation, ensuring delivery within scope, schedule, and budget • Work globally with IT teams to implement R&D solutions and ensure FDA, EMA, and other health-agency compliance • Drive compliance with IT Quality and Viatris SDLC processes, change management, and testing procedures • Collaborate with solutions leads and business partners to ensure technologies meet business requirements • Support vendor relationships and escalate system issues promptly • Own and support R&D IT systems

🎯 Requirements

• Bachelor's degree in science, IT, or a relatable field • 7 years’ of Regulatory business process knowledge and strong hands-on technical experiences configuring, migrating and integrating Veeva RIM Vaults and other R&D solutions • 5 years’ hands-on experience with software design and development, system integrations, analytics report builds • 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 • Hands-on experience implementing, configuring, migrating and integrating Veeva Vault RIM platform including Registrations, Submissions & Archive Vaults • Broad technical knowledge, including system integrations, migrations, and SaaS in a regulated environment • Hands-on experience with Java, Python, creating AI agents, and analytics tools including Power BI reports • Previous experience as IT system owner supporting R&D • Experience in regulatory submission planning and tracking, registration management, commitment management and content management • Knowledge of GCP, EMA and FDA regulations and other regulatory compliance standards • Experience with Agile, Waterfall, and Hybrid project management methodologies • Strong analysis and project management skills and attention to detail • Ability to challenge and define requirements with key stakeholders • Ability to manage multiple activities, priorities, and deadlines • Excellent verbal and written communication skills • Ability to work effectively in a global diverse work environment • Ability to identify and communicate key issues in complex situations

🏖️ Benefits

• Competitive salaries • Benefits • Remote flexibility • Inclusive environment