Bristol Myers Squibb (BMS) is inviting applications for the position of Senior Specialist – APMC Data Management in Hyderabad, India. This opportunity is ideal for professionals with experience in regulatory systems, pharmaceutical quality operations, and supply chain data management.
If you have experience working with Veeva Vault RIM, SAP Batch Release Hub, eCTD submissions, and pharmaceutical regulatory documentation, this role offers an opportunity to work with one of the world’s leading biopharmaceutical companies transforming patient lives through science.
The role involves working closely with CMC, supply chain, regulatory, and quality teams to ensure compliance with global pharmaceutical regulations and product lifecycle management processes.
Job Details
- Position: Senior Specialist – APMC Data Management
- Company: Bristol Myers Squibb
- Location: Hyderabad, Telangana, India
- Job Type: Full-Time
- Experience Required: Minimum 3 years
- Industry: Biopharmaceutical / Pharmaceutical / Regulatory Operations
Key Responsibilities
The selected candidate will support regulatory and supply chain data operations within multiple enterprise systems.
Regulatory Systems & Data Operations
- Manage daily operations in Veeva Vault RIM, Veeva Quality Systems, and regulatory content repositories.
- Extract and review submission registration data and regulatory documentation.
- Assess data accuracy within eCTD and CTD Module 3 submissions.
SAP & Supply Chain Configuration
- Configure product release activities in SAP Batch Release Hub.
- Manage customer release checks and issue resolution processes.
- Support authorized supply chain maps and product release workflows.
Regulatory & CMC Data Management
- Review CMC assessments and regulatory change controls.
- Ensure digital documents are correctly managed within regulatory systems.
- Maintain consistency between manufacturing, regulatory, and supply chain data.
Compliance & Process Improvement
- Ensure compliance with GMP standards and BMS policies.
- Escalate regulatory or data discrepancies to relevant stakeholders.
- Identify opportunities to improve regulatory and quality workflows.
Required Qualifications
Candidates applying for the Senior Specialist – APMC Data Management role should have:
Education
- Bachelor’s degree in:
- Pharmaceutical Sciences
- Chemistry
- Life Sciences or related discipline
Experience
- Minimum 3 years experience in:
- Pharmaceutical regulatory operations
- Quality compliance
- Supply chain data management
Technical Knowledge
Strong understanding of:
- eCTD submissions and CTD Module 3 documentation
- SAP Batch Release Hub
- Veeva Vault RIM / Veeva QMS
- Regulatory lifecycle management
- Pharmaceutical supply chain data and Bills of Materials
Regulatory Knowledge
Working knowledge of:
- 21 CFR Part 11
- EU Annex 11
- Data Integrity principles
- GMP compliance
Key Skills
- Analytical thinking and problem solving
- Cross-functional collaboration
- Strong documentation and communication skills
- Attention to detail in regulatory data review
Benefits of Working at Bristol Myers Squibb
Bristol Myers Squibb offers a supportive and innovative workplace focused on scientific advancement and employee growth.
Employees benefit from:
- Competitive salary and benefits
- Global career development opportunities
- Collaborative research environment
- Work with cutting-edge biologics and cell therapy programs
- Opportunities to contribute to life-saving medicines
Salary (Estimated)
Based on similar roles in the Indian biopharma industry:
₹9,00,000 – ₹16,00,000 per year
Actual compensation depends on experience, skills, and internal policies.
How to Apply
