Senior Manager, Global Regulatory Sciences - CMC, Biologics
321730 - 389865 zł / rocznieBristol Myers Squibb
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.
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.
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?
- Exposure to cutting‑edge science - You'll 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.
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.
Location
Warsaw‑PL
Equal Opportunity Employer
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
#J-18808-Ljbffr