Bristol Myers Squibb (BMS) has announced an opening for the Regulatory Specialist, Portfolio Acceleration and Analytics position in Hyderabad, Telangana. This opportunity is particularly relevant for professionals interested in Regulatory Affairs, global regulatory submissions, regulatory intelligence, compliance analytics, product lifecycle activities and regulatory operations within the pharmaceutical industry.
The BMS Regulatory Specialist will support a broad range of global regulatory activities, including Module 1 documentation, Health Authority certificates, regulatory submission deliverables, product divestitures and deletions, asset integration, Health Authority queries, analytics and monthly dashboards.
Candidates interested in building a career across pharmaceutical Regulatory Affairs and regulatory operations can review the complete responsibilities and application details below.
Key Responsibilities
As a Regulatory Specialist, Portfolio Acceleration and Analytics at BMS, responsibilities include:
- Maintain SharePoint resources and support Global Regulatory Team (GRT) member transitions.
- Support execution of regulatory strategies and associated operational activities.
- Coordinate cross-functionally to generate periodic internal milestone reports.
- Support regulatory intelligence activities and perform basic analyses as directed.
- Assist in planning and managing critical global regulatory submission deliverables.
- Support registration samples and various Module 1 documents for ex-US and ex-EU markets.
- Request regulatory certificates from Health Authorities such as the FDA, EMA and Swissmedic and manage related notification processes.
- Coordinate document shipping and administrative activities such as scanning, copying and shipping labels.
- Upload relevant regulatory documents to Virtual Data Rooms (VDRs) during product divestiture activities.
- Gather information from Country Regulatory Managers to support product deletion strategies.
- Track product deletion notifications to country regulatory Health Authorities.
- Support asset integration by uploading incoming documents into BMS systems and maintaining accurate metadata.
- Perform document remediation activities as directed.
- Support responses to Health Authority queries and shortage notifications.
- Schedule RRT meetings and communicate relevant timelines.
- Prepare response templates to improve submission readiness.
- Support submission of responses for publishing.
- Assist in preparing Global Regulatory Sciences analytics and monthly dashboards covering submissions, approvals, milestones and key achievements.
- Adopt appropriate analytics and technology solutions to improve business processes and regulatory activities.
Qualification & Eligibility
Important: The supplied BMS job description does not specify a mandatory educational degree or minimum years of experience for this position.
Based on the functional responsibilities of the role, candidates with an educational background relevant to Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Clinical Research, Regulatory Affairs or related scientific disciplines may find the position aligned with their profile. However, these degrees should be treated as role-aligned backgrounds, not official BMS eligibility requirements, unless confirmed on the application portal.
Relevant knowledge or exposure may include:
- Pharmaceutical Regulatory Affairs
- Global regulatory submissions
- Regulatory documentation and publishing
- Module 1 documentation
- Regulatory intelligence
- Health Authority correspondence
- Document and metadata management
- Regulatory compliance and analytics
- Microsoft SharePoint
- Dashboards and reporting
- Cross-functional coordination
- FDA, EMA and other global Health Authority processes
BMS also specifically states that candidates are encouraged to apply even when their resume does not perfectly align with every aspect of the position.
Who Should Consider This Role?
This BMS Regulatory Specialist position may be particularly relevant for candidates already working in or seeking opportunities related to Regulatory Affairs, Regulatory Operations, Regulatory Submissions, Regulatory Intelligence, Regulatory Information Management, Regulatory Publishing, pharmaceutical compliance or portfolio management.
Because the official description does not state a minimum experience requirement, candidates should assess their eligibility against the responsibilities listed in the BMS application portal rather than assuming that the vacancy is specifically a fresher or experienced-candidate position.
Key Skills
Regulatory Affairs | Regulatory Operations | Global Regulatory Submissions | Module 1 Documentation | Regulatory Intelligence | Health Authority Queries | FDA | EMA | Swissmedic | SharePoint | Regulatory Compliance | Regulatory Analytics | Dashboard Reporting | Document Management | Metadata Management | Regulatory Publishing | Product Lifecycle Management
Why Join Bristol Myers Squibb?
Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering medicines for patients with serious diseases.
The company highlights:
- Opportunities to work on global pharmaceutical and regulatory activities
- Cross-functional collaboration
- Exposure to regulatory submissions and Health Authority processes
- Opportunities to adopt analytics and technology in regulatory operations
- Employee benefits, services and development programs
- A workplace culture centered on passion, innovation, urgency, accountability, inclusion and integrity
- Workplace accommodations and support for people with disabilities
The exact onsite/hybrid requirement should be confirmed from the BMS application portal, as BMS assigns positions to different occupancy models based on job responsibilities.
Salary
BMS has not disclosed compensation for this vacancy in the provided job posting.
For structured-data purposes only, an estimated market-aligned salary range of approximately ₹6,00,000–₹12,00,000 per year may be considered for a Regulatory Specialist-level pharmaceutical role in Hyderabad. This is an estimate and not an official salary range provided by Bristol Myers Squibb. Actual compensation can vary based on experience, skills, internal grade and company policy.
How to Apply
