Associate Director, Regulatory CMC Cell and Gene Therapy

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.

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.

What's In It For You?

• Breadth of portfolio: Work across small molecules, biologics, combination products, and cell therapies — building a genuinely rare and versatile skill set
• Global scope: Your work will span markets worldwide, giving you exposure to regulatory systems and stakeholders across the US, EU, and beyond
• Visibility and influence: This is a senior individual contributor role with real strategic weight — your voice shapes decisions at the program level
• Career growth: Operating at this level of regulatory complexity, with this level of independence, is the kind of experience that opens doors, both within BMS and across the industry
• Mission-driven work: At BMS, the science you support has the potential to transform and save lives and that's not just a tagline. It's something you'll feel every day

The Bottom Line

This role is an exceptional opportunity for a seasoned CMC regulatory professional who is ready to step into a position of real strategic leadership and to do it in an organization that values expertise, rewards initiative, and operates at the frontier of biomedical innovation.

If you're ready to bring your skills, your judgment, and your passion for regulatory science to a role that will challenge and reward you in equal measure, we'd love to hear from you.

#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.

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 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.

R1601014 : Associate Director, Regulatory CMC Cell and Gene Therapy