Regulatory Specialist, Portfolio Acceleration and Analytics

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 Responsibilities Responsibilities include but not limited to: SharePoint Maintenance Activities; Support GRT member transition by setting up transition form (operational) Execution of Regulatory Strategy Liaise cross-functionally to generate periodic internal milestone report Regulatory Intelligence Performs simple analyses as directed Global Regulatory Submissions Support Support planning and managing timely deliverable of critical regulatory deliverables (registration samples) and various Module 1 documents for ex-US,ex-EU countries Request certificates from respective Health Authority (FDA, EMA, Swiss Medic) and manage notification process Shipping of documents, as required Admin- scanning, copying, shipping label   undefined Product Divestiture: Upload relevant documents into the Virtual Data Room (VDR) for potential buyers Product Deletions: Gather information from the Country Regulatory Managers for Product Deletions Strategy Tracks deletion notifcations to country Reg HA Asset Integration: Upload incoming documents to the BMS systems, ensure correct update of meta data; Remediation of documents, as directed HA queries / Shortage Notifications Schedule RRT meetings and communicate timelines Set up response templates to ensure submission readiness Submission of responses for publishing Analytics / Compliance Activities Support preparation of GRS analytics and monthly dashboards, eg submission, Approvals, key achievements, miles stones   Technology & Analytics Adoption  – Embrace and apply analytics and  technologies to the BoW activities and process. 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