R&D and Regulatory Systems Lead

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

📋 Description

• Collaborate with Regulatory Affairs and various R&D teams to grasp technological requirements and ensure that global processes and systems are compliant and reflective of cross-functional needs.

• Offer a robust understanding of digital capabilities that support global R&D business operations.

• Keep track of emerging global health authority mandates and evaluate their impact on systems.

• Formulate and implement requirements to guarantee compliance.

• Partner with business users to identify needs and convert them into functional and technical specifications.

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

• Manage and enhance Veeva RIM Vault, which includes software packaging, application implementation, and Vault API integrations.

• Oversee the administration, improvements, fixes, configurations, and regular updates of RIM Vaults.

• Lead technical design efforts and improve integrations between systems.

• Design, architect, and spearhead the development of complex applications.

• Oversee assigned projects through implementation, ensuring adherence to scope, schedule, and budget.

• Engage globally in end-to-end R&D solution implementations and regulatory compliance.

• Promote compliance with IT Quality as well as Viatris SDLC, change management, and quality/testing processes.

• Collaborate with solution leaders and business partners to confirm that technology aligns with business needs.

• Support vendor relationships and escalate system-related issues.

⛳️ Requirements

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

• A decade of experience in Regulatory business processes, coupled with extensive hands-on technical expertise in configuring, migrating, and integrating Veeva RIM Vaults and other R&D solutions.

• Ten years of practical experience in software design and development, system integrations, and analytics report creation.

• Prior experience in the pharmaceutical sector with a solid comprehension of R&D & Regulatory business processes.

• Experience with validated GxP environments, including implementation, documentation, and change management is essential.

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

• Comprehensive technical knowledge, with hands-on experience in designing and implementing system integrations, as well as working with migrations and SaaS in a regulated setting.

• Hands-on experience in designing and building solutions with Java, Python, creating AI agents, and utilizing analytics tools, including developing Power BI reports.

• Demonstrated success in formulating technology strategies aligned with business goals.

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

• Familiarity with business processes related to 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 models.

• Strong analytical and project management skills, along with great attention to detail.

• Ability to challenge requirements with key stakeholders to ensure they are detailed and clearly defined.

• Capability to address highly complex enterprise-wide technical challenges.

• Proficiency in navigating a dynamic and challenging environment while managing multiple tasks, priorities, and deadlines.

• Exceptional verbal and written communication skills.

• Functions well in and values a diverse global work environment.

• Possesses a broader perspective and can identify and effectively communicate critical issues in complex situations.

• Veeva RIM Vault certification is preferred; Veeva certification is desirable.

• Advanced degrees are an advantage.

🏝️ Benefits

• Competitive salaries.

• Remote flexibility.

• Inclusive workplace culture.

• Equal opportunity employment.