Bristol Myers Squibb (BMS) has announced an opening for the position of Regulatory Specialist, Portfolio Acceleration and Analytics in Hyderabad, Telangana. This BMS Regulatory Specialist job is an excellent opportunity for candidates interested in Regulatory Affairs, global regulatory submissions, regulatory intelligence, compliance analytics, and pharmaceutical regulatory operations.
The selected Regulatory Specialist will support global regulatory activities involving Module 1 documents, Health Authority certificates, submission deliverables, regulatory analytics, product deletion activities, asset integration, HA queries and regulatory documentation. Candidates interested in building a career in pharmaceutical Regulatory Affairs at BMS can review the complete details below.
BMS Regulatory Specialist Job Overview
| Particulars | Details |
|---|---|
| Company | Bristol Myers Squibb (BMS) |
| Position | Regulatory Specialist, Portfolio Acceleration and Analytics |
| Requisition ID | R1605215 |
| Location | Hyderabad, Telangana, India |
| Employment Type | Full Time |
| Department/Domain | Regulatory Affairs |
| Key Areas | Regulatory Submissions, Intelligence, Analytics & Compliance |
| Industry | Pharmaceutical / Life Sciences |
| Posted | August 21, 2026 |
About the BMS Regulatory Specialist Role
The BMS Regulatory Specialist, Portfolio Acceleration and Analytics position supports multiple areas of global regulatory operations.
The role involves supporting regulatory strategy execution, global regulatory submissions, regulatory intelligence, Health Authority queries, analytics, compliance activities, product divestitures, product deletions and asset integration.
A significant part of the position involves coordinating regulatory documentation and ensuring that important regulatory deliverables are prepared and managed according to required timelines.
Key Responsibilities
Regulatory Strategy Support
- Work cross-functionally to generate periodic internal milestone reports.
- Support execution of regulatory strategies and related operational activities.
- Assist with SharePoint maintenance activities.
- Support Global Regulatory Team member transitions by setting up transition forms.
Global Regulatory Submissions
- Support the planning and timely delivery of critical regulatory deliverables.
- Coordinate registration samples and regulatory documentation.
- Support preparation and management of various Module 1 documents for countries outside the US and EU.
- Request certificates from relevant Health Authorities.
- Manage applicable notification processes.
- Support document scanning, copying, shipping and shipping-label preparation.
Health Authority Documentation
The Regulatory Specialist may coordinate requests for certificates from major Health Authorities, including:
- US Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Swissmedic
This requires effective document coordination and tracking to support regulatory submission readiness.
Regulatory Intelligence Responsibilities
The selected candidate will perform basic regulatory intelligence analyses as directed by the team.
This may involve collecting and reviewing regulatory information required to support portfolio and regulatory activities.
Product Divestiture & Product Deletion Support
The Regulatory Specialist will support product lifecycle activities, including:
- Uploading relevant documentation to the Virtual Data Room (VDR) for potential buyers during product divestitures.
- Gathering information from Country Regulatory Managers for product deletion strategies.
- Tracking product deletion notifications submitted to country Regulatory Health Authorities.
Asset Integration
Responsibilities related to asset integration include:
- Uploading incoming regulatory documents into BMS systems.
- Ensuring regulatory metadata is updated correctly.
- Supporting remediation of regulatory documents as directed.
- Maintaining appropriate document organization and data quality.
Health Authority Queries & Shortage Notifications
The BMS Regulatory Specialist will also support Health Authority query management and shortage notification activities.
Key responsibilities include:
- Scheduling RRT meetings.
- Communicating regulatory timelines.
- Setting up response templates.
- Supporting submission readiness.
- Coordinating responses for publishing and submission.
Regulatory Analytics & Compliance
The role supports preparation of GRS analytics and monthly regulatory dashboards.
Analytics may cover:
- Regulatory submissions
- Regulatory approvals
- Key achievements
- Regulatory milestones
- Portfolio activities
- Compliance-related metrics
Candidates should be comfortable working with data and adopting analytical tools and technologies within regulatory operations.
Technology & Analytics Adoption
BMS expects the Regulatory Specialist to embrace and apply relevant technology and analytics solutions to regulatory activities and business processes.
This makes the opportunity particularly relevant for candidates interested in the intersection of Regulatory Affairs, regulatory operations, data analytics and pharmaceutical technology.
Qualification & Eligibility
Candidates should focus on demonstrating relevant knowledge or experience in areas such as:
- Regulatory Affairs
- Regulatory Operations
- Global Regulatory Submissions
- Regulatory Documentation
- Module 1 Documents
- Regulatory Intelligence
- Health Authority Coordination
- Regulatory Compliance
- Pharmaceutical/Life Sciences Operations
- Document Management
- Analytics and Dashboard Reporting
- SharePoint or related document-management platforms
- Key Skills for the BMS Regulatory Specialist Job
Candidates can highlight relevant skills such as Regulatory Affairs, Global Regulatory Submissions, Module 1 Documentation, Regulatory Intelligence, FDA, EMA, Swissmedic, Health Authority Queries, Regulatory Compliance, VDR, Regulatory Analytics, Dashboard Reporting, SharePoint, Document Management, Metadata Management, Product Lifecycle Management and Cross-Functional Coordination.
Benefits of Working at BMS
According to BMS, employees have access to a range of competitive benefits, services and programs designed to support professional and personal goals.
The company also emphasizes:
- Career growth and development opportunities.
- Exposure to global pharmaceutical operations.
- Collaboration with cross-functional teams.
- Opportunities to work on meaningful projects supporting medicines and patients.
- A workplace culture focused on passion, innovation, urgency, accountability, inclusion and integrity.
- Workplace flexibility depending on the occupancy classification assigned to the position.
Specific compensation and employee benefits can vary according to role, location and company policies.
Work Model
BMS uses different occupancy structures, including site-essential, site-by-design, field-based and remote-by-design positions.
The supplied posting does not clearly identify which specific occupancy classification applies to this Hyderabad Regulatory Specialist opening.
Where a position is classified as site-by-design, BMS states that it may follow a hybrid model requiring at least 50% onsite presence. Candidates should confirm the exact working arrangement during the recruitment process.
How to Apply
