Manager I, Submission Management

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: Summary
Supports end-to-end regulatory activities for assigned projects including leading the preparation and compilation of compliant US IND and marketing complex submissions for global health authorities and supporting continuous improvement initiatives.

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 drive the execution of the Global Submission Plan.
Track and ensure timely progress of submission components to Health Authorities. Apply risk and critical path management practices.
Execute submission management and publishing activities in the eCTD publishing system for efficient eCTD production and delivery to HA portals.
Lead/represent team in regulatory/submission meetings driving deliverable and publishing timelines.
Lead/participate in department initiatives within scope. Develop/update procedural documentation as needed.
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

Drive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams.
Lead the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.
Ensure cross functional alignment for IND and marketing 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.

Requirements

• Required degrees certifications and/or licensure relevant to role. BA/BS degree science / technology field preferred
• Minimum number of years of relevant experience expected. 5 years relevant submissions experience
• Proficient knowledge of global regulatory practices submission guidelines and requirements; able to identify and resolve issues with support from senior team members
• Strong analytical and critical thinking skills for solution development decision-making and implementation; generates alternative solutions by weighing risks and dependencies
• Effective communication skills in English (written and oral) including presenting complex information and collaborating with non-English speakers
• Solid project management abilities: defines objectives sets priorities tracks progress manages resources and communicates status and risks within project teams
• Builds collaborative relationships by understanding stakeholder needs priorities and processes; drives team communication for successful project delivery
• Advanced proficiency with desktop software and regulatory systems with the ability to instruct others; understands 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 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.

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