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Position Summary:

The Senior Manager, Submission Management Clinical Trials, supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant clinical trial submissions for global health authorities and supporting continuous improvement initiatives.

Position Responsibilities

Regulatory Strategy & Submission

• Collaborate with global and local stakeholders to define clinical trial submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
• Assess core submission deliverables to ensure compliance, prepare and distribute global CTA dossiers, and manage data required for EU CTIS and substantial modifications.
• Monitor and influence the regulatory assessment process, drive negotiations with stakeholders to resolve information requests, and communicate regulatory changes to ensure ongoing compliance.
• Manage and track queries, commitments, and submissions with health authorities, collaborate with subject matter experts for responses, and provide periodic status updates on commitments.

Continuous Improvement Initiatives

• Drive initiatives that promote innovation and simplify processes to enhance efficienices for BMS teams.
• Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.
• Ensure consistency of Clinical Trial Applications across projects, studies, and countries, aligning with regulatory standards and best practices.
• Effectively communicate regulatory changes to the business to maintain compliance and support continuous improvement.

Team Leadership

• Lead a team of direct reports managing resource and allocation and assigned projects, provide training and mentoring to new staff, and support team with development and innovation.

Degree Requirements

• BA/BS degree, science/technology field preferred

Experience Requirements

7+ years relevant regulatory submissions experience

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 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.

R1599218 : Senior Manager, Submission Management Clinical Trials