Associate Director, Regulatory Information Management & Innovation
Warsaw, Masovian Voivodeship, Poland · Hybrid
$362k–$438k/yr
Senior$29B raised
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 …
Skills: Regulatory Information Management, AI Implementation, Project Management, Veeva RIM, GxP Compliance
Manager, Regulatory Information Management & Innovation
Warsaw, Masovian Voivodeship, Poland · Hybrid
$163k–$197k/yr
Senior$29B raised
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 …
Skills: Regulatory Information Management, UAT Script Design, Business Requirements Management, Veeva RIM, AI-enabled Capabilities
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 …
Skills: Pharmacovigilance, Safety Aggregate Reporting, Process Design, Process Mapping, Regulatory Compliance
Clinical Research Associate (m/w/d) – Region: Stuttgart, Heilbronn, Heidelberg
Heidelberg, Baden-Württemberg, Germany · Remote OK
Mid level$29B raised
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 …
Skills: Clinical Monitoring, ICH GCP, Site Qualification, Data Integrity, Regulatory Compliance
Senior Therapeutic Area Specialist, Cardiovascular Community - Tucson, AZ/Phoenix SE
Gilbert, Arizona, United States · On-site
$124k–$150k/yr
Senior$29B raised
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 …
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 …
Skills: Clinical Trial Leadership, Protocol Development, GCP/ICH, Clinical Data Review, Medical Writing
Principal Scientist - Cell Therapy Translational Research
Seattle, Washington, United States · On-site
$152k–$185k/yr
Senior+$29B raised
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 …
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 …
Skills: MES Recipe Authoring, Electronic Batch Record (EBR) Design, GMP Compliance, Logic Design, Technical Leadership
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 …
Senior Therapeutic Area Specialist, Cardiovascular Community - Minneapolis S, MN
Minneapolis, Minnesota, United States · On-site
$124k–$150k/yr
Senior$29B raised
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 …
At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise a…
Skills: SAS Programming, CDISC Standards, SDTM, ADaM, FDA Electronic Data Submission
Therapeutic Area Specialist, Cardiovascular / Pharmareferent (m/w/d) - Gebiet 10202: Berlin & Südbrandenburg
Berlin, Germany · Remote OK
Mid level$29B raised
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 …
Skills: Cardiology Sales, Omnichannel Strategy, Stakeholder Management, Digital Communication Tools, Strategic Planning
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 …
Skills: Computer System Validation, cGXP, 21 CFR Part 11, SDLC, Equipment Qualification
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 …
Skills: MES Configuration, Recipe Authoring, Troubleshooting, System Maintenance, cGMP Compliance
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 …
Skills: MES Configuration, Recipe Authoring, Troubleshooting, System Maintenance, cGMP Compliance
Medical Science Liaison, Cell Therapy Autoimmune (CTAI) - (IN, OH, KY, W. PA)
Indianapolis, Indiana, United States · Remote OK
$168k–$204k/yr
Mid level$29B raised
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 …
Skills: Scientific Exchange, KOL Relationship Management, Clinical Presentations, Cross-functional Collaboration, Time Management
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 …
Skills: Sterility Assurance, Aseptic Process Validation, Contamination Control Strategy, cGMP, Microbiology
Associate Director, Commercial AI and Advanced Analytics- Immunology
Princeton, New Jersey, United States · Hybrid
$168k–$203k/yr
Senior$29B raised
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 …
Skills: Marketing Mix Modeling, Causal Inference, Bayesian Modeling, Python, R
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 …
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 …
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$362k–$438k/yr
Full-time
bachelor degree
Competitive Benefits, Services and Programs, Incentive Cash, Stock Opportunities
Posted 38d ago
Apply by Oct 31
~40 hrs/week
Responsibilities
Lead the design and implementation of Regulatory Information Management systems and AI-enabled capabilities to improve operational efficiency and data quality. Partner with IT and business teams to manage project milestones, ensure GxP compliance, and drive the adoption of automation and analytics.
Requirements
Requires a BA/BS degree in a science or technology field and at least 7 years of relevant RIM or submissions experience. Candidates must possess expert knowledge of global regulatory practices and the ability to lead complex, cross-functional AI and system initiatives.
Full job 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.
Position Summary The Associate Director, Regulatory Information Management and Innovation will support working with business and IT teams to design future releases and integrations, evolving system functionality to meet new Health Authority / business needs, working with the vendor to evaluate new platform releases.
Position Responsibilities
Maintains comprehensive knowledge of the assigned Regulatory Capabilities and/or Processes
Identify and track progress against key project milestones partnering with business, quality and other enabling functions and any external providers to ensure overall project success
Actively engage with leadership from business case development through program delivery, broker the delivery of critical programs within the portfolio, ensure organizational alignment on scope, schedule, quality, benefits and implement and monitor appropriate controls to proactively deal with barriers to completion
Support the development, deployment and maintenance of processes, procedures, and training materials in compliance with Global GxP requirements, BMS Global Quality Standards
Maintains global expert level knowledge of the assigned Regulatory Capabilities and/or Processes
Leads system and/or process implementations and/or system enhancements in collaboration with Information Technology Business Partners and according to validation rules
Lead the evaluation, design, and adoption of AI‑enabled capabilities across Regulatory Information Management and submission platforms (e.g., Veeva RIM), driving measurable improvements in data quality, process effectiveness, operational efficiency, and inspection readiness within approved governance and compliance frameworks.
Partner with business, IT, Quality, and external vendors to define AI use cases, influence platform roadmaps, and oversee pilot‑to‑production deployment of AI‑assisted solutions (e.g., automation, analytics, content intelligence), ensuring appropriate validation, documentation, risk management, and change adoption.
Work with RIM System Business Lead and IT Business Partner to support development, approval, and execution of business case approval for improvement projects
Lead the development of business plans to optimize assigned regulatory capabilities and/or processes
Requirements
BA/BS degree, science / technology field preferred
Experience Requirements
7+ years relevant RIM or submissions experience
Key Competency Requirements • Expert knowledge of global regulatory practices, submission guidelines and requirements.
Anticipates and resolves complex issues at the cross-functional level.
Generates alternative solutions by weighing risks and considering dependencies.
Support of other RISM members sharing expertise, providing guidance and serving as a SME/mentor.
Excellent command of the English language, and able to communicate effectively in both written and oral forms.
Simplifies complex issues or topics to design clear and impactful presentations, sessions, or workshops.
Leverages project management methodologies and lessons learned from prior experience to optimize portfolio, program, and project execution.
Drives and facilitates risk-mitigation strategies and contingency plans with key stakeholders. Facilitates change management and ensures business adoption/implementation of the plan.
Prioritizes and manages multiple complex projects or programs. Determines and manages resources and tracks metrics and budget needs, as applicable.
Subject matter expert who thinks strategically and is able to make decisions in alignment with group/company objectives.
Leverages collaborative relationships to address complex or sensitive issues and resolve conflict.
Drives discussions with functional leads to define and align on objectives for cross-functional and enterprise initiatives.
Strategic understanding of AI, automation, and advanced analytics as applied to Regulatory Information Management, with demonstrated ability to assess business value, risk, compliance impact, and scalability across a global regulatory ecosystem.
Knowledge and subject matter expertise with computer systems in an R&D environment.
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:
Warsaw - PL: zł361,740 - zł438,337
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 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. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.
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 [email protected]. 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.
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [email protected]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
R1601861 : Associate Director, Regulatory Information Management & Innovation
Related keywords
Regulatory Information ManagementRIMVeeva RIMAIAutomationAdvanced AnalyticsGxPHealth AuthoritySubmission PlatformsContent IntelligenceValidationRisk ManagementChange AdoptionR&DGlobal Regulatory PracticesBusiness Case
At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome.
Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients.
Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.
Review our Social Media Community Guidelines at: https://www.bms.com/social-media-community-guidelines.html
Offices: 3401 Princeton Pike, Lawrence Township, NJ 08648, US · 南京西路1717号, 17楼, 上海, 上海 200040, CN · 345 Park Avenue, New York, New York 10154-0037, US · 950 E Paces Ferry Rd NE, Atlanta, GA 30326, US · Avenue de Finlande 4, Braine-l'Alleud, Walloon Region 1420, BE
biotechnologyinnovationgreat place to workpharmaceuticalsresearch and developmentand healthcareConsumer GoodsMobile AppsSocial Media MarketingApps
At Bristol Myers Squibb, we work every day to transform patients’ lives through science. That work inspires some of the most interesting, meaningful, and life-changing careers you’ll experience. Join us and pursue innovative ideas alongside some of the brightest minds in biopharma, collaborating with a team rich in diversity of experiences, and perspectives. We have built a sustainable pipeline of potential therapies and are leveraging translational medicine and data analytics to understand how we can deliver the right medicine to the right patient, at the right time, to achieve the best outcome.
Whether in a scientific, business or supporting function, a career at BMS means you’ll be inspired every day to grow and thrive through opportunities that are uncommon in scale and scope. Here, you’ll be on the cutting edge of powerful innovation in oncology, hematology, immunology, cardiovascular disease, and fibrosis, with colleagues united in the mission to help patients.
Through the Bristol Myers Squibb Foundation, we also promote health equity and seek to improve health outcomes of populations disproportionately affected by serious diseases and conditions. Our mission is to give new hope to help patients prevail over serious disease – it drives everything we do.
Review our Social Media Community Guidelines at: https://www.bms.com/social-media-community-guidelines.html
Offices: 3401 Princeton Pike, Lawrence Township, NJ 08648, US · 南京西路1717号, 17楼, 上海, 上海 200040, CN · 345 Park Avenue, New York, New York 10154-0037, US · 950 E Paces Ferry Rd NE, Atlanta, GA 30326, US · Avenue de Finlande 4, Braine-l'Alleud, Walloon Region 1420, BE
biotechnologyinnovationgreat place to workpharmaceuticalsresearch and developmentand healthcareConsumer GoodsMobile AppsSocial Media MarketingApps