Senior Manager, Global Regulatory Sciences - CMC, Biologics

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. Are You Ready to Shape the Future of Global Medicine? Imagine starting your day knowing that the work you do directly influences whether life-changing therapies reach patients around the world. That's not a distant possibility - it's your everyday reality in this role. At Bristol Myers Squibb, we're on a mission to transform patients' lives through science. And we need someone like you \- a sharp, driven CMC regulatory professional - to help us get there. So, What Will You Actually Be Doing? You'll be at the heart of our Global Regulatory Sciences CMC (GRS-CMC) team, playing a pivotal role in bringing innovative biologics therapies - through the regulatory journey. Think of yourself as the connective tissue between our science, our supply chain, and the global health authorities who ultimately decide whether a product reaches patients. Day to day, you will: * Own the CMC content \- leading the development, compilation, and review of the Quality Module for regulatory submissions, including clinical trial applications, new marketing applications, and post-approval dossiers. Your name is on the work, and your expertise makes it sing. * Be the bridge between Global Regulatory Sciences (GRS), Product Development and Supply (PDS) - giving you unparalleled visibility across the entire product development ecosystem. * Interact with Global Regulatory Teams \- leading the strategy for submission of post-approval changes to worldwide markets. * Be a strategic voice \- providing CMC regulatory guidance to project teams, helping to anticipate risks before they become problems and crafting mitigation strategies that keep programmes on track. * Drive global change management \- assessing manufacturing change controls for worldwide impact and guiding technical teams through complex global processes. What's In It For You? This isn't just another regulatory role. Here's what makes it genuinely different: * Exposure to cutting-edge science \- You'll work across Work across a broad biologics portfolio, from established modalities to next- generation therapeutics. * Global impact, every day \- Your regulatory decisions will influence submissions and manufacturing strategies across multiple markets. You won't be a cog in the machine - you'll be shaping the machine itself. * A seat at the strategic table \- This role positions you as a key interface between regulatory, science, and operations. That kind of cross-functional influence accelerates your career in ways that siloed roles simply can't. * Real career growth \- You'll build and refine your ability to interpret and apply global regulatory frameworks, manage complex multi-stakeholder projects, and develop the leadership skills to take on even greater responsibility. * A team that values your voice \- We genuinely mean it when we say we value courage - the courage to raise risks, to challenge assumptions, and to share good news just as openly. Your perspective matters here. Who Are We Looking For? You bring 4–6+ years of pharmaceutical or CMC regulatory experience (minimum BA/BS), and you're someone who thrives when the work is complex and the stakes are high. Specifically, you'll stand out if you have: * Deep knowledge of CMC regulatory requirements for advanced therapies, biologics, cell therapy, and/or small molecules — across both development and post-approval phases * Hands-on understanding of pharmaceutical development processes — from upstream and downstream manufacturing through to analytical methods and combination products * Proficiency with electronic regulatory dossier systems for submission creation and tracking * A proven track record of working across multifunctional teams, managing competing priorities without losing momentum * Strong oral and written communication skills — you can translate technical complexity into clear, compelling regulatory narratives * A solution-oriented mindset — you don't just flag problems, you come equipped with options The Kind of Person Who Thrives Here You're not someone who waits to be told what to do. You take ownership, you ask the hard questions, and you hold yourself to a high standard - then raise the bar for those around you. You're curious about regulations not as red tape, but as a framework through which patients ultimately get access to the medicines they need. You listen before you speak, seek out different perspectives, and when you see something that needs to be said - you say it. If that sounds like you, we want to hear from you. Ready to make your mark on global healthcare? Join BMS and help us deliver on our promise to patients — one submission at a time. Apply now and take the next step in a career that truly matters. #LI-Hybrid 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: zł321,730 - zł389,865 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 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. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. 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. R1601840 : Senior Manager, Global Regulatory Sciences - CMC, Biologics