Bristol Myers Squibb Hiring Regulatory Specialist

Bristol Myers Squibb (BMS) is a major global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for serious diseases, particularly in areas like oncology, immunology, hematology, and cardiovascular conditions, with key products including Opdivo, Eliquis, and Revlimid, aiming to transform patient lives through science. Headquartered in Princeton, New Jersey, BMS has a significant global presence and invests heavily in research and development to address unmet medical needs.

Post : Regulatory Specialist, Portfolio Acceleration and Analytics

Job Description
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.

Additional Information
Location : Hyderabad - TS - IN
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Portfolio Acceleration and Analytics
End Date : 30th September 2026