Senior Manager, Global Regulatory Sciences CMC, Biologics

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: 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. Thats not a distant possibility - its your everyday reality in this role.

At Bristol Myers Squibb were on a mission to transform patients lives through science. And we need someone likeyou- a sharp driven CMC regulatory professional - to help us get there.

So What Will You Actually Be Doing

Youll 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 bridgebetween 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.

Whats In It For You

This isnt just another regulatory role. Heres what makes it genuinely different:

• Exposure to cutting-edge science- Youll 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 wont be a cog in the machine - youll 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 cant.
• Real career growth- Youll build and refine your ability to interpret and applyglobal 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 perspectivemattershere.

Who Are We Looking For

You bring46 years of pharmaceutical or CMC regulatory experience(minimum BA/BS) and youre someone who thrives when the work is complex and the stakes are high. Specifically youll stand out if you have:

• Deep knowledge ofCMC regulatory requirementsfor advanced therapies biologics cell therapy and/or small molecules across both development and post-approval phases
• Hands-on understanding ofpharmaceutical development processes from upstream and downstream manufacturing through toanalytical methodsandcombination products
• Proficiency withelectronic regulatory dossier systemsfor submission creation and tracking
• A proven track record of working acrossmultifunctional teams managing competing priorities without losing momentum
• Strongoral and written communication skills you can translate technical complexity into clear compelling regulatory narratives
• A solution-oriented mindset you dont just flag problems you come equipped with options

The Kind of Person Who Thrives Here

Youre 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. Youre 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 healthcareJoin 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 doesnt 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.

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 employees 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 . Visit 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: Protection

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