Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t 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\xe2\x80\x99ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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: .

Position Summary

Regulatory Information and Submission Management is an organization that delivers Health Authority submissions and product data to support the BMS portfolio and sets the strategic business direction and related processes oversight for GRS systems. The Senior Specialist manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.

Key Responsibilities

• Tracks progress of all components for submission to Health Authorities
• Interacts with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced
• Supports research for legal due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections
• Facilitate submission team meetings with team support
• May participate in focused projects related to their scope of work
• Prepare Cover Letter, FDA Forms and submission content plan for Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission)
• Attend Submission Team and kick off meetings, represent GSM and drive submission publishing timelines
• Coordinate Initial IND Kick off meeting submission
• Coordinate IND, NDA, BLA and Orphan Drug Annual Reports
• Develop/Update job aid documents for departmental process
• Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist)
• Coordinate eCTD submissions with ISL Intercon Team

• Qualifications & Experience

• BA/BS degree, science / technology field preferred
• 3+ years relevant submissions experience
• Proficient knowledge of global regulatory practices, electronic submission guidelines and requirements
• Assists in the implementation of short- and long-term goals within own work group within GSM
• Come prepared with a solution to questions and issues as they arise
• Effective written and verbal communication skills
• Works Independently
• Ability to prioritize, manage multiple tasks and strong attention to detail
• Proposes alternative solutions for submission-related situations.
• Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, eCTD viewers and web based applications) and be technically savvy with such system

If you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol-Myers Squibb