Associate Director, Regulatory CMC Cell and Gene Therapy

Associate Director, Regulatory CMC Cell and Gene Therapy

BMS - Bristol-Myers Squibb

Warsaw, Poland

Why This Role?

Regulatory science at its best isn't about paperwork — it's about getting transformative medicines to patients safely, efficiently, and without unnecessary delay. As an Associate Director within BMS's Global Regulatory Sciences – CMC team, you'll be the strategic bridge between the science of how a medicine is made and the global regulatory frameworks that govern how it reaches patients.

This is a role for someone who wants to do more than review documents. You'll shape regulatory strategy for some of the most complex and exciting product types in modern medicine — small molecules, biologics, combination products, and cell therapies — and you'll do it at a company that is genuinely redefining what's possible in oncology, immunology, and beyond.

If you're looking for a role where your expertise directly influences drug development timelines, global market access, and ultimately patient outcomes — this is it.

What You'll Actually Be Doing

Owning CMC Regulatory Strategy — End to End

• You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management. That means you won't just be executing someone else's strategy — you'll be developing it, owning it, and driving it forward independently.
• For candidates who've spent years waiting for a seat at the strategic table, this role puts you there from day one. Your input will directly shape how BMS navigates Health Authority expectations across global markets, with real consequences for program timelines and commercial outcomes.

Being the Translator Between Science and Regulation

• One of the most valuable things you'll do in this role is help technical teams understand what regulatory success looks like in practice. You'll interpret global regulations and guidance, identify where risks and opportunities lie, and help formulate mitigation strategies before problems become delays. You'll also anticipate regulatory paradigm shifts before they happen, giving BMS's development teams a competitive advantage in a fast-moving landscape.
• This is the kind of work that builds a reputation. When you're the person who consistently sees around corners and helps teams avoid costly missteps, people notice and your influence grows.

Leading Health Authority Interactions

• You'll interface directly with Health Authorities on CMC submissions and CMC-related issues. Whether you're preparing background packages, leading HA meetings, or crafting responses to complex queries, you'll be representing BMS at the highest levels of regulatory dialogue. These are high-stakes, high-visibility moments and they're also some of the most professionally rewarding.

Driving Global Change Management

• Every manufacturing change at BMS has global regulatory implications, and you'll be the person assessing them. You'll guide technical teams on the practical realities of change management across markets, ensuring that necessary updates are implemented efficiently without putting approvals or supply continuity at risk. Your work here directly protects BMS's ability to supply patients without interruption.

Shaping Process and Policy

• Beyond individual projects, you'll contribute to CMC policies and procedures, participate in teams assessing the global regulatory landscape, and actively look for opportunities to improve how the function operates. This is your chance to leave a mark not just on a product but on how BMS does regulatory science.

What You Bring

• 8+ years of pharmaceutical industry experience, with at least 5+ years in CMC regulatory strategy — ideally spanning small molecules, biologics, or cell therapy;
• A BA/BS degree at minimum (advanced scientific or regulatory degree a strong plus);
• A track record of leading teams and cross-functional projects — you know how to run a meeting, manage competing priorities, and bring people to alignment;
• Solid knowledge of global CMC regulatory requirements across development and post-approval stages, and the experience to translate regulatory guidance into practical team direction;
• Familiarity with electronic dossier systems and Regulatory Information Management tools;
• The ability to work independently on complex, multi-faceted challenges — with the judgment to know when to escalate and when to drive forward.

Beyond the technical credentials, you're someone who communicates with clarity and honesty, holds yourself (and others) to high standards, and brings a genuine sense of ownership to everything you do. You thrive in a globally connected environment, navigating across functions, geographies, and organizational layers with ease.