Regulatory Operations Jobs (NOW HIRING)

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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.

Key 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 Leaders with team engagement initiatives, logistics for team events, off-sites, and recognition programs
• Coordinate onboarding plans for new hires across the Onc/Hem Regulatory team, 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 Onc/Hem 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

Preferred

• 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

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for ...