Associate Director, Regulatory Excellence ICVN

Bristol-Myers Squibb; New Jersey; On-site; USD 173,000 - 210,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Paid vacation

Paid sick leave

Volunteer days

Summer hours flexibility

Leaves of absence

Global Shutdown

Wellbeing support

Job summary

Bristol Myers Squibb is seeking an Associate Director, Regulatory Excellence ICVN to lead business management for the GRS ICV & Neuroscience teams in a highly matrixed environment. You will shape deliverables, drive governance, and coordinate regulatory milestones with internal and external partners.

The role requires strategic partnership, experience with regulatory submissions, and a track record of process improvement, SOP development, and stakeholder engagement in a global biotech setting.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
• 7–10 years in business operations, regulatory ops, or related roles in a complex environment.
• Experience leading cross-functional initiatives and guiding senior leaders.
• Proven ability to deliver outcomes in a fast-paced, matrixed setting.

Responsibilities

• Lead governance materials, executive briefings, and decision-ready content for senior leadership.
• Coordinate cross-team information for portfolio reviews and regulatory milestones.
• Drive Regulatory Excellence initiatives and SOP updates for ICVN regulatory operations.
• Support onboarding, training, and adoption of regulatory tools and digital capabilities.
• Build relationships with Clinical Development, CMC, Medical Affairs, Finance, and HR.

Skills

Leadership

Cross-functional

Regulatory operations

Communication

MS Office proficiency

Stakeholder management

Project management

Regulatory submissions

Process improvement

Regulatory tools

Education

Bachelor’s in Life Sciences/Pharmacy

Advanced degree preferred (MSc/PhD/PharmD)

Tools

SharePoint

Planisware

Veeva

Job description

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.

Key Responsibilities

• Operational & Leadership Support 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.
• Regulatory Portfolio Coordination & Tracking 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.
• Regulatory Excellence & Process Improvement 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.
• Team & 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.
• Cross-Functional Coordination 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.

Qualifications Required

• 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)
• Ability to work effectively in a fast-paced, dynamic environment
• Experience 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)

Functional Competencies

• Deep organizational awareness and the ability to influence across matrixed environments with credibility as a recognized expert
• Strong leadership, execution, and follow-through on projects and initiatives of strategic importance
• Effective communication and stakeholder management
• Ability to solve highly complex, sometimes novel problems by developing practical options and recommendations with broad organizational impact
• Collaboration across functions and levels
• Ability to anticipate business and industry issues, adapt quickly, and contribute meaningful input to strategy development

Compensation Overview

Princeton - NJ - US: $173,350 - $210,058 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606187 : Associate Director, Regulatory Excellence ICVN Data Privacy Link

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.