Senior Manager, R&D and Regulatory Systems

Role Description

We are seeking an experienced IT Project Leader with a strong background in R&D and Regulatory Affairs. The ideal candidate will manage end-to-end projects, coordinate cross-functional teams, ensure compliance with regulatory requirements, and deliver projects within scope, budget, and timeline. This position manages system enhancements and is the IT platform owner for assigned R&D and Regulatory systems. This position will manage external and internal resources.

• Manage the successful completion of IT projects from conception to implementation ensuring successful project delivery in scope, on schedule and within budget.
• Communicate project status and manage issues/risks in a timely manner and promptly escalate issues to leadership.
• Responsible for ensuring project/vendor contracts are accurate and approved in a timely manner. Ensure successful completion of project Statements of Work including keeping the project scope, budget and timelines on track.
• IT platform owner for Regulatory intelligence and publishing systems and other assigned systems, collaborating with IT teams to maintain deployed systems including managing break fixes, incident management work and system security.
• Application technical lead supporting the successful implementation, system lifecycle, evolving enhancements, requirement analysis, design, configuration, data migration, system integration, testing and validation activities.
• Drive compliance with the IT Quality processes and Viatris SDLC processes, including the IT change management and quality/testing process for assigned projects/systems. Create/Review lifecycle documentation for assigned systems.
• Support vendor relationships for assigned systems, ensuring system issues are communicated promptly to leadership.
• Provide strong working knowledge of technical capabilities used to support R&D and regulatory business processes and deliver industry leading processes.
• Understand business processes and identify regulatory & R&D trends and policies that could impact current systems.
• Monitor emerging industry and health authority requirements to assess business and system impact and develop the requirements to ensure compliance.
• Establish and maintain strong relationships with customers.
• Collaborate with key business users to identify business needs and translate these needs to user requirements. Translate user requirements into technical requirements and implement solutions to meet these requirements.
• Provide business analysis techniques including business and functional requirements gathering, process modeling, interviewing, user stories, prototyping, data flows, and root cause analysis.
• Provide good working knowledge of data standards and conventions for Regulatory and R&D systems.
• Provide guidance to direct report(s) and perform other duties as assigned.

Qualifications

• Bachelor's degree in science, IT, or a relatable field required. Advanced degrees are a plus.
• 5+ years of previous experience as IT platform owner and people leadership required.
• 8+ years of project management experience in the life science domain.
• Experience with project management methodologies such as Agile, Waterfall, and Hybrid approaches.
• Knowledge of GCP, EMA + FDA regulations and other regulatory compliance standards.
• Hands-on experience with validated GxP environments including documentation and change management 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 implementing and supporting global R&D and Regulatory applications and processes for electronic lab notebooks, lab inventory & informatics solutions, regulatory solutions (eg dossier management, submissions, publishing, labeling intelligence and regulatory insights).
• Strong business analysis skills including building detailed process maps of current and future processes.
• Hands on experience supporting large transformational projects.
• Ability to operate in a 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.
• Can see the larger picture as well as identify and efficiently communicate key issues and solutions in complex situations.
• Preferred hands on experience in Agentic AI and python.

Requirements

• Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000.00 - $193,000.00 USD.

Benefits

• At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Company Description

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.