Associate Director, Regulatory Excellence ICVN

Bristol Myers Squibb • Princeton, NJ

1d • Hybrid

About The Position

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Position Summary Bristol Myers Squibb is seeking an Associate Director, Regulatory Excellence, ICVN to lead business management activities within the GRS ICV & Neuroscience organizations. This role serves as a strategic partner to leadership, driving execution of portfolio priorities, operational planning, compliance, and regulatory excellence initiatives. The successful candidate will be recognized internally as a subject matter expert in business operations, 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.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, or a related field; advanced degree (MSc, PhD, PharmD) preferred
• Minimum 7–10 years of experience in business operations, program/project management, regulatory operations, or related roles within a complex, matrixed biopharmaceutical or healthcare environment, including experience leading cross-functional initiatives of strategic importance
• Demonstrated ability to lead complex projects, develop plans, lead meetings, and deliver outcomes with considerable independence in a fast-paced, highly matrixed environment
• Recognized as an internal expert in own field, with strong judgment, credibility, and the ability to represent the function as a primary contact on complex projects or cross-functional initiatives
• Excellent written and verbal communication skills
• Proficiency in Microsoft Office Suite (PowerPoint, Excel, Word, Teams)

Nice To Haves

• Supporting senior leaders or working in a business operations or chief of staff–type capacity
• Experience in pharmaceutical, biotechnology, or healthcare environments
• Familiarity with portfolio management, resource planning, or operational analytics
• Experience with tools such as SharePoint, Planisware, Veeva, or similar platforms
• Experience with global regulatory submissions (NDAs, BLAs, MAAs or equivalent) and health authority interactions
• Exposure to process improvement methodologies (e.g., Lean, Six Sigma)

Responsibilities

• Serve as a strategic operational partner to the Therapy Areas VPs, 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 ICVN Regulatory teams, 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 Therapy Area VPs in a timely manner and leads mitigation
• 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 ICVN Regulatory groups to assist leadership in allocation decisions
• Liaise with Global Regulatory Strategic Operations and project management teams to ensure alignment on submission timelines and deliverables
• Lead the Regulatory Excellence agenda for the ICVN TAs 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 ICVN 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, 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
• Support the Therapy Area VPs and Team Leaders with team engagement initiatives, logistics for team events, off-sites, and recognition programs
• Coordinate onboarding plans for new hires across the ICVN Regulatory teams, partnering with HR and IT to ensure readiness on Day 1
• Help maintain and update organizational charts, team rosters, and role descriptions as the team evolves
• Assist with performance cycle coordination including timeline tracking, calibration logistics, and goal-setting reminders
• Serve as a culture ambassador, helping to reinforce team values, inclusion efforts, and engagement across a hybrid/distributed team
• Build and lead relationships with key partners in Clinical Development, CMC, Medical Affairs, Commercial, Finance, and HR, and represent BMS as a primary operational and technical contact for designated cross-functional initiatives, contracts, or projects
• Support coordination of cross-functional regulatory workstreams and ensure clear communication of regulatory team needs and timelines to partner functions
• Help prepare the ICVN Regulatory team's inputs for enterprise-level regulatory operations initiatives and BMS-wide programs
• Serve as a point of contact for administrative and operational inquiries directed at VP

Benefits

• wellbeing support
• retirement and financial protection benefits
• insurance offerings (medical, dental, vision, life and disability)
• Flexible Time Off (FTO)
• 11 paid company holidays
• 160 hours of paid vacation annually for new hires
• 3 optional holidays
• paid sick leave
• up to two paid volunteer days per year
• summer hours flexibility
• leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
• annual Global Shutdown between Christmas Day and New Year's Day

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level