Bristol Myers Squibb (BMS), a global biopharmaceutical leader, has announced a new Regulatory Specialist – Portfolio Acceleration and Analytics job opening in Hyderabad. This role offers an excellent opportunity for early-career regulatory professionals to work on global regulatory submissions, portfolio analytics, and health authority interactions while supporting life-changing medicines.
If you are searching for regulatory affairs jobs in Hyderabad, pharma regulatory specialist roles, or entry-level regulatory operations jobs, this BMS opportunity is highly relevant.
Job Overview: Regulatory Specialist – Portfolio Acceleration & Analytics
The Regulatory Specialist will provide operational and coordination support to global and country regulatory teams, ensuring timely delivery of regulatory portfolio milestones in compliance with global and local regulatory requirements.
This role sits at the intersection of regulatory operations, analytics, and portfolio acceleration, offering exposure to FDA, EMA, and global health authorities.
Key Responsibilities
Global Regulatory Support
- Maintain regulatory SharePoint workspaces
- Support Global Regulatory Team (GRT) member transitions
- Coordinate cross-functional regulatory activities
Regulatory Strategy & Intelligence
- Generate internal milestone and progress reports
- Perform basic regulatory intelligence analyses
Global Regulatory Submissions
- Support Module 1 documentation for ex-US and ex-EU submissions
- Coordinate registration samples and regulatory deliverables
- Request certificates from FDA, EMA, Swissmedic
- Manage document scanning, shipping, and submission logistics
Divestitures, Deletions & Asset Integration
- Upload documents to Virtual Data Rooms (VDRs)
- Track product deletion notifications to Health Authorities
- Support asset integration and metadata remediation
Health Authority Queries & Shortages
- Schedule RRT meetings
- Prepare response templates
- Support submission publishing
Analytics & Compliance
- Assist in preparation of monthly regulatory dashboards
- Track submissions, approvals, milestones, and achievements
Eligibility & Qualifications
Education
- Bachelor’s degree in Pharmacy, Life Sciences, Natural Sciences, or Healthcare-related field
Experience
- 0–2 years of experience in the pharmaceutical industry
Key Skills & Competencies
- Knowledge of global Module 1 regulatory requirements
- Basic understanding of FDA, EMA, and international regulations
- Exposure to Veeva Vault Regulatory Operations
- Experience or familiarity with CMC variations and HA queries
- Strong documentation, organizational, and communication skills
- Proficiency in MS Office, Outlook, and regulatory systems
- Excellent command of English language
Why Join Bristol Myers Squibb?
- Work on global regulatory portfolios with real patient impact
- Exposure to cutting-edge regulatory analytics and digital tools
- Collaborative, inclusive, and high-performance work culture
- Hybrid work model (site-by-design role)
- Commitment to diversity, inclusion, and accessibility
Salary (Estimated)
💰 ₹6,00,000 – ₹9,00,000 per annum (CTC)
(Indicative salary range based on industry standards for Regulatory Specialist roles in Hyderabad)
How to Apply
