Associate Director, Regulatory CMC Cell and Gene Therapy

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: This Role

Regulatory science at its best isnt about paperwork its about getting transformative medicines to patients safely efficiently and without unnecessary delay. As an Associate Director within BMSs Global Regulatory Sciences CMC team youll 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. Youll 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 youll do it at a company that is genuinely redefining whats possible in oncology immunology and beyond.

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

What Youll Actually Be Doing

Owning CMC Regulatory Strategy End to End

• Youll 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 wont just be executing someone elses strategy youll bedeveloping it owning it and driving it forward independently.
• For candidates whove 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 youll do in this role is help technical teams understand what regulatory success looks like in practice. Youll interpret global regulations and guidance identify where risks and opportunities lie and help formulate mitigation strategies before problems become delays. Youll also anticipate regulatory paradigm shifts before they happen giving BMSs development teams a competitive advantage in a fast-moving landscape.
• This is the kind of work that builds a reputation. When youre the person who consistently sees around corners and helps teams avoid costly missteps people notice and your influence grows.

Leading Health Authority Interactions

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

Driving Global Change Management

• Every manufacturing change at BMS has global regulatory implications and youll be the person assessing them. Youll 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 BMSs ability to supply patients without interruption.

Shaping Process and Policy

• Beyond individual projects youll 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 least5 years in CMC regulatory strategy ideally spanning small molecules biologics or cell therapy
• ABA/BS degreeat minimum (advanced scientific or regulatory degree a strong plus)
• A track record ofleading teams and cross-functional projects you know how to run a meeting manage competing priorities and bring people to alignment
• Solid knowledge ofglobal CMC regulatory requirementsacross development and post-approval stages and the experience to translate regulatory guidance into practical team direction
• Familiarity withelectronic dossier systemsand Regulatory Information Management tools
• The ability towork independentlyon complex multi-faceted challenges with the judgment to know when to escalate and when to drive forward

Beyond the technical credentials youre 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.

Whats 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 thats not just a tagline. Its something youll 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 youre 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 wed love to hear from you.

#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

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at 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 . 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.