Senior Specialist, Medicinal Product Data Management

By Admin ยท Regulatory Affairs

HYDERABAD (IN)ONSITEPOSTED: 8/26/2026
PHARMAFull-time
HIRING ORGANIZATIONBRISTOL MYERS SQUIBBPharmaceuticals
BR

ROLE DEFINITION & RESPONSIBILITIES

Role Overview

Senior Specialist, Medicinal Product Data Management responsible for operational management of medicinal-product regulatory information, including EVMPD and DMP data collection, entry, quality control, maintenance, reporting, compliance monitoring, and regulatory-process support. The role operates within Regulatory Information Management (RIM) and requires working knowledge of EVMPD, IDMP, SPOR, Veeva Vault, EV Web, and global regulatory practices.

Core Responsibilities

Coordinate EVMPD maintenance through data collection, data entry, and data quality control for EVMPD and DMP.
Maintain understanding of assigned EVMPD processes and IDMP business processes.
Manage daily workload and independently address questions associated with assigned regulatory processes.
Contribute to enhancements within established areas of expertise.
Execute operational aspects of enabled processes according to BMS procedures.
Create, update, and execute reports in the RIM system for new data entries and updates to existing medicinal-product data.
Collaborate with stakeholders and subject-matter experts to identify solutions and resolve ongoing or potential issues.
Support management in developed areas of expertise.

Regulatory Compliance & Quality

Recognize and report data-compliance issues.
Assess how data-compliance issues affect assigned processes and related downstream processes.
Support internal audits, health-authority inspections, and corrective action plans.
Maintain data accuracy and quality across medicinal-product regulatory information.
Develop working knowledge of global regulatory practices and requirements related to IDMP and EVMPD.

Regulatory Information Management

Manage regulatory information for medicinal products and vaccines.
Perform data entry and submission activities through Veeva Vault and EV Web.
Apply knowledge of Regulatory Information Management processes and systems.
Work with EVMPD, IDMP, and/or SPOR-related data and processes.
Understand regulatory requirements affecting medicinal-product information management.

Systems & Technical Skills

Work with RIM systems and standard desktop applications.
Create and maintain reports supporting regulatory information workflows.
Troubleshoot issues within relevant applications and systems.
Adapt quickly to new software, systems, and procedures.
Maintain strong attention to detail when handling regulated product data.

Qualifications & Experience

BA/BS degree preferred in a science or technology field.
3-5 years of pharmaceutical experience preferred.
More than 3 years of experience managing regulatory information for medicinal products or vaccines, including data entry and submissions through Veeva Vault and EV Web.
Solid regulatory knowledge and prior Regulatory Information Management experience.
Clear knowledge and experience with EVMPD, IDMP, and/or SPOR.
Knowledge of standard desktop applications and RIM systems, including effective troubleshooting.
Ability to adapt to new software and procedures.
Strong attention to detail.

Work Arrangement

Location: Hyderabad, Telangana, India.
Full-time position.
The supplied posting does not explicitly identify the specific occupancy category for this requisition. BMS explains that site-essential roles require full onsite presence, while site-by-design roles may support hybrid work with at least 50% onsite presence. The exact occupancy classification should therefore be confirmed on the application portal.

REQUIRED VERIFIED SKILLS

EVMPD
IDMP
SPOR
Regulatory Information Management
RIM
Medicinal Product Data Management
DMP
Regulatory Data Entry
Data Quality Control
Veeva Vault
EV Web
RIM Reporting
Regulatory Compliance
Global Regulatory Requirements
Data Management
Data Troubleshooting
Pharmaceutical Industry Experience

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting

ORGANIZATION CONTEXT & CULTURE

Bristol Myers Squibb is actively hiring for this position.

INDUSTRY: Pharmaceuticals

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