Lead Program Manager - Regulatory Information Management

Lead Program Manager - Regulatory Information Management

Capgemini is seeking a well experienced Program Manager to lead a high-impact transformation initiative in Regulatory Information Management (RIM) services that shapes the future of global regulatory operations and drives business excellence. This role combines strategic PMO leadership with hands-on project execution, ensuring delivery of a multi-phase program aligned with global best practices and business objectives. As a trusted leader, you will oversee governance, planning, and execution across complex workstreams, fostering collaboration among diverse stakeholders and ensuring compliance with regulatory standards. If you thrive in a fast-paced environment, excel at managing complexity, and are passionate about delivering outcomes that matter, this is your opportunity to make a global impact. Note : candidate must be located in the United States. Remote work eligible.

Your role

Program Governance & Oversight

Establish and maintain a robust governance framework for program success. Define and track KPIs, milestones, and deliverables across workstreams. Ensure alignment with strategic goals and RIM best practices.

Project Planning & Execution

Develop integrated program plans, work breakdown structures, and detailed schedules. Drive execution from initiation to closure, applying Agile methodologies. Maintain focus on scope, timelines, and quality deliverables.

Risk & Issue Management

Proactively identify, assess, and mitigate risks. Maintain comprehensive risk and issue logs with clear ownership. Escalate critical issues with actionable recommendations.

Stakeholder Engagement & Communication

Partner with Organizational Change Management (OCM) to develop engagement plans. Facilitate steering committees, workshops, and working sessions. Deliver executive dashboards and status reports to leadership.

Compliance & Quality Assurance

Ensure all deliverables meet regulatory and quality standards. Collaborate with QA teams to address compliance concerns.

Your skills and experience

10 years of proven experience in managing complex, high impact programs in life sciences. Strong understanding of Regulatory Information Management (RIM) processes in life sciences. Demonstrated experience in software program / project management. Expertise in Agile frameworks and tools (JIRA, Confluence). Exceptional organizational skills and attention to detail. Experience leading cross-functional teams across geographies. PMP or PgMP certification preferred. English proficiency required; French language skills a plus.

Life at Capgemini

Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer :

• Flexible work
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child / elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups
• Disaster Relief

About Capgemini Engineering

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has 65,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet. Capgemini Engineering is an integral part of the Capgemini Group, a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2024 global revenues of 22.1 billion.

Disclaimer

Capgemini is an Equal Opportunity Employer encouraging inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity / expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law. This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and / or changing the way this job is performed, provided that such accommodations do not pose an undue hardship. Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact. Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process. Click the following link for more information on your rights as an Applicant http : / / www.capgemini.com / resources / equal-employment-opportunity-is-the-law Applicants for employment in the US must have valid work authorization that does not now and / or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.