Senior Specialist, Global Submission Management - CMC

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 Senior Specialist Submission Management supports end-to-end regulatory activities for assigned projects, including executing the preparation and compilation of compliant US IND and marketing maintenance submissions for global health authorities.

Position Responsibilities

• Collaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
• Collaborate with teams to execute the Global Submission Plan.
• Track and ensure timely progress of submission components to Health Authorities.
• Execute submission management and publishing activities in the eCTD publishing tool for efficient eCTD production and delivery through HA portals.
• Represent team in regulatory/submission meetings driving deliverable and publishing timelines.
• Participate in department initiatives within scope.
• Execute required activities in RIM systems (Veeva RIM) and use available tools to generate reports and track submission content.
• Coordinate non-eCTD submissions with international teams.
• Continuous Improvement Initiatives
• Support initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams.
• Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.
• Ensure consistency of IND and marketing applications across projects, studies, and countries, aligning with regulatory standards and best practices.
   

Degree Requirements

• Required degrees, certifications, and/or licensure relevant to role. BA/BS degree, science / technology field preferred

Experience Requirements

• Minimum number of years of relevant experience expected. 3+ years relevant submissions experience

Key Competency Requirements

• Foundational knowledge of global regulatory practices, submission guidelines, and requirements
• Strong critical thinking and problem-solving skills; proposes alternative solutions for submission-related and project situations
• Effective stakeholder engagement and communication, including proficiency in English (written and oral) and ability to communicate with non-English speakers
• Ability to execute and prioritize non-complex projects with attention to detail; communicates project status and updates to relevant stakeholders
• Demonstrates basic presentation skills and adapts content for diverse audiences
• Proficiency with desktop software and regulatory systems with the ability to instruct others; understand how non-regulatory systems interact with regulatory systems. Embrace the use of artificial intelligence and automation tools.

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: zł144,100 - zł174,616

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.

R1601847 : Senior Specialist, Global Submission Management - CMC