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.

Position Summary:

The role is to provide coordination and operational support to cross-functional regulatory teams and Country Regulatory to ensure regulatory portfolio deliverables are delivered to plan and in compliance with global processes and appropriate local regulatory requirements.

Position Responsibilities:

Global Regulatory Support

• SharePoint Maintenance Activities; Support GRT member transition by setting up transition form

Execution of Regulatory Strategy

• Liaise cross-functionally to generate periodic internal milestone report

Regulatory Intelligence

• Performs simple analyses as directed

Global Regulatory Submissions Support

• Support planning and managing timely deliverable of critical regulatory deliverables (registration samples) and various Module 1 documents for ex-US,ex-EU countries
• Request certificates from respective Health Authority (FDA, EMA, Swiss Medic) and manage notification process
• Shipping of documents, as required
• Admin- scanning, copying, shipping label  

Support of Divestitures / Product Deletions / Product Termination / Asset Integration

• Product Divestiture: Upload relevant documents into the Virtual Data Room (VDR) for potential buyers
• Product Deletions: Gather information from the Country Regulatory Managers for Product Deletions Strategy
• Tracks deletion notifcations to country Reg HA
• Asset Integration: Upload incoming documents to the BMS systems, ensure correct update of meta data; Remediation of documents, as directed

HA queries / Shortage Notifications

• Schedule RRT meetings and communicate timelines
• Set up response templates to ensure submission readiness
• Submission of responses for publishing

Analytics / Compliance Activities

• Support preparation of GRS analytics and monthly dashboards, eg submission, Approvals, key achievements, miles stones

Degree Requirements:

• Minimum of a Bachelor degree in a Natural Science, Pharmacy, or other Healthcare-related field

Qualifications/Requirements: 

• 0- 2 years in pharmaceutical industry

Key Competency Requirements:

• Strong expertise in handling international regulatory submissions with in‑depth knowledge of global Module 1 requirements.
• Proven experience in preparing and managing CMC variation filings.
• Demonstrated experience in responding to and managing Health Authority Queries across global markets.
• Advanced proficiency in Veeva Vault, with hands‑on experience supporting regulatory operations workflows, reports and dashboards creation.
• Ability to identify and drive continuous improvement opportunities by leveraging AI and digital technologies to enhance process efficiency, quality, and scalability within regulatory operations.
• Basic understanding of FDA, EMA or other  Health Authorities and Reporting regulations and standards;
• Act as a role model & set a good example
• Identify and communicate routine issues.
• Establish strong working relationsships
• Good communication and organizational skills and a meticulous eye for details
• Interact w/ key partners or HA on routine matters w/ supervisory consultation.
• Ability to make  decisions in their sphere of influence
• dependently work on multiple assignments
• Ability to work as part of a team that supports global functions with a high level of professionalism in the pharmaceutical and scientific documentation discipline.
• Must possess an excellent command of language (English)
• Proficiency in standard office technology, including Microsoft Suite, Outlook Mail/Calendar and willing to learn additional applications as needed

• Good understanding of pharmaceutical or medical terminology

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.

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 [email protected]. 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 [email protected]. 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.

R1598462 : Regulatory Specialist, Portfolio Acceleration and Analytics