Senior Specialist – APMC Data Management
Location: Hyderabad, Telangana, India
Job Type: Full-Time
Experience Required: 3+ years in regulatory, quality, or technical operations within biopharmaceuticals
Job ID: R1596850
About Bristol Myers Squibb (BMS)
Bristol Myers Squibb is a global biopharmaceutical leader committed to transforming patients’ lives through science. At BMS, our work spans cutting-edge therapies, cell and gene therapy innovations, and global supply chain operations, creating opportunities for employees to develop meaningful careers. With a culture grounded in passion, accountability, inclusion, and innovation, BMS empowers professionals to drive change across the life sciences industry.
Our Hyderabad site plays a critical role in regulatory data management, supply chain operations, and global compliance initiatives, supporting BMS’s mission to deliver safe and effective medicines worldwide.
Role Overview
The Senior Specialist, APMC Data Management will manage and execute regulatory data operations, ensuring accuracy, compliance, and alignment across multiple systems, including Veeva Vault RIM, Quality Veeva Systems, SAP Batch Release Hub, and regulatory content repositories. This role will partner closely with CMC, Supply Chain, and Quality teams to optimize global product lifecycle management, including post-approval changes, renewals, and regulatory submissions.
This position requires 3+ years of experience in regulatory or quality operations within the biopharmaceutical industry, strong technical and analytical skills, and proficiency in handling complex regulatory and supply chain data.
Key Responsibilities
Execute daily operations across regulatory and quality systems, including Veeva Vault RIM, Quality Veeva Systems, and document repositories, ensuring data integrity and completeness
Perform configuration and management activities in SAP Batch Release Hub, including product release test configuration, customer release checks, and issue resolution
Manage Change Control Restriction Management activities, including CMC assessments, document validation, and system updates
Handle operations within Authorized Supply Chain Maps and Document Data Extraction, including data entry, exception handling, and configuration
Validate and assess data from eCTD and CTD Module 3 submissions, ensuring accuracy, completeness, and consistency with manufacturing and regulatory records
Collaborate with cross-functional teams to align priorities, escalate unresolved issues, and proactively manage risks to support timely product releases
Identify opportunities for process improvement within regulatory and data management operations
Ensure full compliance with GMP standards, BMS policies, and global regulatory requirements
Provide support across additional electronic systems, including Change Controls, Deviations, and Document Management Platforms
Required Qualifications & Experience
Education: Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related discipline
Experience: Minimum 3 years in technical, quality, or regulatory roles within the biopharmaceutical industry
Strong understanding of biologics, pharmaceutical, or cell therapy operations, including drug substance, drug product, and finished product release
Experience with electronic quality management systems (eQMS), regulatory management systems, or supply chain systems, including Veeva RIM, Veeva QMS, SAP
Knowledge of industry regulations: 21 CFR Part 11, EU Annex 11, Data Integrity principles
Strong analytical skills with the ability to assess accuracy and consistency of manufacturing and regulatory data
Excellent communication, collaboration, and organizational skills, capable of working effectively in cross-functional teams
Ability and willingness to travel abroad for training or business purposes
Why Join BMS
Be part of a company transforming patients’ lives through science globally
Work on regulatory, quality, and supply chain operations at scale, impacting global product approvals
Competitive benefits and programs supporting work-life balance, professional development, and global mobility
Opportunity to contribute to innovative therapies and cell/gene therapy pipelines
Inclusive and accessible workplace culture supporting career growth and diversity
Career Advancement
At BMS, we encourage employees to take initiative and innovate within their roles. The Senior Specialist, APMC Data Management, serves as a critical contributor to global regulatory operations, providing a foundation for future leadership opportunities in regulatory affairs, quality, or data management.
Apply now to join a team committed to excellence, compliance, and transforming healthcare on a global scale.
Explore BMS Careers: https://careers.bms.com
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