Regulatory Specialist - Portfolio Acceleration and Analytics

Roles & Responsibilities:
• Maintain regulatory SharePoint workspaces and support Global Regulatory Team (GRT) member transitions
• Coordinate cross-functional regulatory activities and generate internal milestone/progress reports
• Perform basic regulatory intelligence analyses to support regulatory strategy
• Support Module 1 documentation for ex-US and ex-EU submissions
• Coordinate registration samples, regulatory deliverables, and request certificates from FDA, EMA, Swissmedic
• Manage document scanning, shipping, and submission logistics
• Upload documents to Virtual Data Rooms (VDRs) and track product deletion notifications to Health Authorities
• Support asset integration, metadata remediation, and response to Health Authority queries
• Schedule RRT meetings, prepare response templates, and assist in submission publishing
• Assist in preparation of monthly regulatory dashboards and track submissions, approvals, milestones, and achievements

Qualification:
Bachelor’s degree in Pharmacy, Life Sciences, Natural Sciences, or Healthcare-related field

Experience:
0–2 years in the pharmaceutical industry

Skills:
Knowledge of global Module 1 regulatory requirements; basic understanding of FDA, EMA, and international regulations; familiarity with Veeva Vault Regulatory Operations; exposure to CMC variations and HA queries; strong documentation, organizational, and communication skills; proficiency in MS Office and Outlook; excellent command of English

About the Organization:
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader committed to discovering, developing, and delivering innovative medicines that help patients worldwide. This Hyderabad role provides early-career regulatory professionals exposure to global submissions, portfolio analytics, and health authority interactions in a collaborative and growth-oriented environment.