Associate Director, Regulatory Excellence & Hematology/Oncology Operations

Responsibilities

• Operational & Leadership Support
• Serve as a strategic operational partner to the VP, leading development of leadership presentations, business reviews, team communications, and strategic planning materials that inform department priorities and decision-making
• Develop operational plans and lead the management cadence for the Onc/Hem Regulatory team, including key leadership meetings, portfolio reviews, and planning cycles, ensuring alignment, follow-through, and compliance with governance expectations
• Lead follow-up on action items, critical deliverables, and leadership commitments, independently resolving or escalating highly complex issues and developing new options to address risks with broad impact on the department
• Lead preparation of governance materials, executive briefings, and decision-ready content for senior leadership and cross-functional forums, exercising considerable latitude in determining objectives, framing recommendations, and shaping deliverables
• Actively identifies organizational risks to the VP in a timely manner and leads mitigation
• Regulatory Portfolio Coordination & Tracking
• Maintain and update portfolio-level tracking tools, dashboards, and milestone reports to provide leadership with visibility into submission timelines, regulatory commitments, and program status
• Coordinate cross-team information gathering to support portfolio reviews, resource discussions, and pipeline updates
• Partner with Regulatory Team Leaders and program teams to monitor and communicate key regulatory milestones, flagging risks or delays proactively
• Support resource tracking and workload monitoring across the Onc/Hem Regulatory group to assist leadership in allocation decisions
• Liaise with Global Regulatory Operations and project management teams to ensure alignment on submission timelines and deliverables
• Regulatory Excellence & Process Improvement
• Lead the Regulatory Excellence agenda for the Onc/Hem TA by driving process improvement initiatives of strategic importance, establishing implementation plans, and ensuring progress is measured, communicated, and sustained
• Identify systemic workflow inefficiencies and develop new approaches to solve highly complex, sometimes novel operational problems that affect team performance, submission quality, and departmental effectiveness
• Help develop, update, and communicate standard operating procedures (SOPs), work instructions, and best practice guides relevant to Onc/Hem regulatory operations
• Coordinate training and onboarding activities for new team members, ensuring smooth integration into team processes, systems, and culture
• Support adoption of new regulatory tools and digital capabilities including Veeva RIM, regulatory intelligence platforms, and AI-assisted authoring tools
• Benchmark regulatory performance, monitor emerging business and industry trends, and provide input into strategy development to strengthen regulatory operations, digital adoption, and organizational effectiveness
• Team & Organizational Effectiveness
• Support the VP and Team

Additional Information

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary Bristol Myers Squibb is seeking an Associate Director, Regulatory Excellence & Hematology/Oncology Operations to lead operational and business management activities within the Oncology/Hematology organization. This role serves as a strategic partner to leadership, driving execution of portfolio priorities, operational planning, compliance, and regulatory excellence initiatives across a team of approximately 45 professionals. The successful candidate will be recognized internally as a subject matter expert in regulatory operations and business management, exercising considerable latitude in shaping deliverables, leading initiatives of strategic importance, and developing solutions to highly complex, sometimes novel problems with broad impact across the department. The role requires anticipating business and industry trends, representing BMS with key internal and external partners, and ensuring effective planning, meeting leadership, and compliant execution across a matrixed environment.

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