R&D and Regulatory Systems Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with Regulatory Affairs and R&D teams to comprehend technological requirements and ensure that global processes and systems adhere to compliance standards.

• Offer insights into digital capabilities that support global R&D business operations.

• Keep track of evolving global health authority requirements and evaluate their impact on systems.

• Formulate and execute requirements to guarantee compliance.

• Work alongside business users to identify their needs and convert them into functional and technical specifications.

• Collect requirements through process modeling, interviews, user stories, prototyping, data flows, and root cause analysis.

• Manage and enhance Veeva RIM Vaults, including package software, application deployment, and Vault API integrations.

• Oversee RIM Vault administration, enhancements, fixes, configurations, and code migrations.

• Deliver technical designs for projects and enhance system integrations.

• Direct projects from implementation to completion, ensuring delivery aligns with scope, schedule, and budget.

• Collaborate globally with IT teams to execute R&D solutions while ensuring compliance with FDA, EMA, and other health agencies.

• Promote adherence to IT Quality and Viatris SDLC processes, change management, and testing protocols.

• Partner with solutions leads and business stakeholders to confirm that technologies fulfill business requirements.

• Manage vendor relationships and escalate system issues in a timely manner.

• Own and support R&D IT systems.

⛳️ Requirements

• Bachelor's degree in science, IT, or a related field.

• A minimum of 7 years of knowledge in Regulatory business processes along with substantial hands-on technical experience in configuring, migrating, and integrating Veeva RIM Vaults and other R&D solutions.

• At least 5 years of hands-on experience in software design and development, system integrations, and building analytical reports.

• Prior experience in the pharmaceutical sector and a strong understanding of R&D and Regulatory business processes.

• Familiarity with validated GxP environments, including implementation, documentation, and change management.

• Practical experience in implementing, configuring, migrating, and integrating the Veeva Vault RIM platform, covering Registrations, Submissions, and Archive Vaults.

• Comprehensive technical knowledge, including system integrations, migrations, and SaaS in regulated settings.

• Experience with Java, Python, developing AI agents, and utilizing analytics tools such as Power BI for report generation.

• Previous experience as an IT system owner supporting R&D.

• Familiarity with regulatory submission planning and tracking, registration management, commitment management, and content management.

• Knowledge of GCP, EMA, and FDA regulations along with other compliance standards.

• Experience with Agile, Waterfall, and Hybrid project management methodologies.

• Strong analytical and project management skills with a keen attention to detail.

• Capability to challenge and define requirements alongside key stakeholders.

• Ability to manage multiple tasks, priorities, and deadlines effectively.

• Excellent verbal and written communication abilities.

• Capability to work efficiently in a global and diverse work environment.

• Skill in identifying and communicating key issues in complex scenarios.

🏝️ Benefits

• Competitive salaries.

• Comprehensive benefits package.

• Flexibility for remote work.

• An inclusive work environment.