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BM

Bristol Myers Squibb

via Workday

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Senior Director, Regulatory Operations

Anywhere
Full-time
Posted 12/8/2025
Direct Apply
Key Skills:
Regulatory Operations
Veeva Vault RIMs
Regulatory Submission Planning
Project Management
Global Regulatory Compliance
Regulatory Publishing Tools
Document Management Systems
Regulatory Lifecycle Management
Communication Skills
Leadership

Compensation

Salary Range

$242K - 293K a year

Responsibilities

Lead and manage a Regulatory Operations team to support global regulatory submission planning, publishing, and lifecycle management, including implementation of Veeva Vault RIMs and compliance with regulatory standards.

Requirements

Bachelor's degree in life sciences or related field, 10+ years in Regulatory Operations in pharma/biotech, experience with Veeva Vault RIMs, knowledge of global regulatory submissions, leadership and project management skills.

Full Description

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. Location: Remote Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Build and manage a Regulatory Operations team to support submission planning, publishing, and lifecycle management. Oversee/lead planning, tracking, publishing, compilation, and archiving efforts in support of regulatory submission activities including INDs, NDAs, BLAs, IND amendments, IMPDs and CTA submissions, EU and Rest of World (ROW) submissions. Lead the implementation and optimization of Veeva Vault RIMs, ensuring alignment with regulatory and business needs. Establish and maintain SOPs, work instructions, and best practices for regulatory operations. Monitor global regulatory operations requirements and ensure compliance with evolving standards. Serve as the primary liaison with publishing vendors, as needed, to ensure compliant electronic submissions. Manage templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and training across functional groups. Education and Experience Bachelor’s degree in life sciences or related field; advanced degree preferred. Minimum of 10+ years in Regulatory Operations within the pharmaceutical or biotech industry. Proven experience implementing and managing Veeva Vault RIMs or similar regulatory systems. Strong knowledge of global regulatory submission formats (eCTD, NeeS, paper) and requirements. Demonstrated success in leading submissions across US, EU, and global markets. Experience building and scaling teams in a high-growth, agile environment. Excellent project management, communication, and leadership skills. Ability to thrive in a fast-paced, dynamic setting with shifting priorities. Skills and Qualifications Experience with regulatory publishing tools and document management systems. Familiarity with regulatory intelligence platforms and submission tracking tools. Strong understanding of regulatory lifecycle management and compliance frameworks. Excellent written and verbal communication skills. Highly organized, with the ability to multi-task and handle pressure well Meticulous with detail and precision Ability to think through a project or task of diverse complexity and execute independently from beginning to end Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing Strong communication and interpersonal skills Should be assertive, proactive, professional, and confident Excellent professional ethics and integrity Flexibility to adapt in a cross-functional and dynamic environment #RayzeBio #LI-Remote 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. Compensation Overview: Remote - United States - US: $241,768 - $292,966 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 then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition 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 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. 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.

This job posting was last updated on 12/9/2025

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