Associate Director, Regulatory Information Management & Innovation

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
The Associate Director Regulatory Information Management and Innovation will support working with business and IT teams to design future releases and integrations evolving system functionality to meet new Health Authority / business needs working with the vendor to evaluate new platform releases.

Position Responsibilities

• Maintains comprehensive knowledge of the assigned Regulatory Capabilities and/or Processes
• Identify and track progress against key project milestones partnering with business quality and other enabling functions and any external providers to ensure overall project success
• Actively engage with leadership from business case development through program delivery broker the delivery of critical programs within the portfolio ensure organizational alignment on scope schedule quality benefits and implement and monitor appropriate controls to proactively deal with barriers to completion
• Support the development deployment and maintenance of processes procedures and training materials in compliance with Global GxP requirements BMS Global Quality Standards
• Maintains global expert level knowledge of the assigned Regulatory Capabilities and/or Processes
• Leads system and/or process implementations and/or system enhancements in collaboration with Information Technology Business Partners and according to validation rules
• Lead the evaluation design and adoption of AIenabled capabilities across Regulatory Information Management and submission platforms (e.g. Veeva RIM) driving measurable improvements in data quality process effectiveness operational efficiency and inspection readiness within approved governance and compliance frameworks.
• Partner with business IT Quality and external vendors to define AI use cases influence platform roadmaps and oversee pilottoproduction deployment of AIassisted solutions (e.g. automation analytics content intelligence) ensuring appropriate validation documentation risk management and change adoption.
• Work with RIM System Business Lead and IT Business Partner to support development approval and execution of business case approval for improvement projects
• Lead the development of business plans to optimize assigned regulatory capabilities and/or processes

Requirements

• BA/BS degree science / technology field preferred
• Experience Requirements
• 7 years relevant RIM or submissions experience
• Key Competency Requirements Expert knowledge of global regulatory practices submission guidelines and requirements.
• Anticipates and resolves complex issues at the cross-functional level.
• Generates alternative solutions by weighing risks and considering dependencies.
• Support of other RISM members sharing expertise providing guidance and serving as a SME/mentor.
• Excellent command of the English language and able to communicate effectively in both written and oral forms.
• Simplifies complex issues or topics to design clear and impactful presentations sessions or workshops.
• Leverages project management methodologies and lessons learned from prior experience to optimize portfolio program and project execution.
• Drives and facilitates risk-mitigation strategies and contingency plans with key stakeholders. Facilitates change management and ensures business adoption/implementation of the plan.
• Prioritizes and manages multiple complex projects or programs. Determines and manages resources and tracks metrics and budget needs as applicable.
• Subject matter expert who thinks strategically and is able to make decisions in alignment with group/company objectives.
• Leverages collaborative relationships to address complex or sensitive issues and resolve conflict.
• Drives discussions with functional leads to define and align on objectives for cross-functional and enterprise initiatives.
• Strategic understanding of AI automation and advanced analytics as applied to Regulatory Information Management with demonstrated ability to assess business value risk compliance impact and scalability across a global regulatory ecosystem.
• Knowledge and subject matter expertise with computer systems in an R&D environment.

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

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