Senior Specialist APMC Data Management Job at Bristol Myers Squibb in Hyderabad. Pharma regulatory, SAP, Veeva systems role with global exposure.
Company Overview
Bristol Myers Squibb is a globally recognized biopharmaceutical organization focused on discovering, developing, and delivering innovative medicines that help patients fight serious diseases. The company is known for its strong research capabilities, cutting-edge biologics development, and commitment to advancing treatments in areas such as oncology, immunology, cardiovascular disease, and cell therapy.
With a strong presence across multiple countries, Bristol Myers Squibb collaborates with healthcare professionals, researchers, and regulatory experts to bring transformative therapies to patients worldwide. The company offers a dynamic and inclusive work environment that encourages professional growth, innovation, and continuous learning for its employees.
For professionals interested in regulatory data management, pharmaceutical supply chain systems, and quality compliance operations, this opportunity provides exposure to advanced digital platforms and global regulatory processes. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Job Location & Employment Type
- Job Location: Hyderabad, Telangana, India
- Employment Type: Full-Time
- Work Model: On-site / Hybrid depending on organizational requirements
- Department: APMC Data Management / Regulatory Operations
This role is designed for professionals who have experience working with regulatory systems, quality management platforms, and pharmaceutical supply chain data. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Open Position
Senior Specialist – APMC Data Management
The selected candidate will play an important role in managing regulatory data, product release information, and digital documentation across multiple enterprise systems used in pharmaceutical operations.
This position involves coordination between regulatory, quality, and supply chain teams to ensure accurate data flow and compliance with global pharmaceutical regulations. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Key Roles & Responsibilities
The Senior Specialist – APMC Data Management will be responsible for supporting operational processes related to regulatory systems and manufacturing data management. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Regulatory Data Operations
- Manage daily operational activities within regulatory platforms such as Veeva Vault RIM and regulatory content repositories.
- Extract and review product registration data associated with regulatory submissions.
- Maintain accurate documentation and ensure regulatory records align with submission requirements.
SAP and Batch Release System Management
- Configure and maintain operational activities within SAP Batch Release Hub.
- Support product release testing configurations and perform system checks.
- Manage customer release validations and address system-related issues promptly.
Change Control & CMC Assessment Support
- Review Chemistry, Manufacturing, and Controls (CMC) assessments within change control systems.
- Maintain digital documentation and perform system updates related to regulatory changes.
- Support alliance partner assessments and ensure regulatory documentation accuracy.
Authorized Supply Chain Mapping
- Manage operational tasks related to Authorized Supply Chain Maps.
- Configure document extraction systems and monitor exceptions.
- Perform data entry and validation tasks to ensure supply chain compliance.
Document Data Extraction Activities
- Configure automated document extraction systems.
- Investigate exceptions or errors during document processing.
- Validate extracted regulatory and manufacturing data.
Regulatory Data Assessment
- Analyze data from eCTD submissions and CTD Module 3 documents.
- Ensure consistency between regulatory documentation and manufacturing information.
- Identify discrepancies between supply chain and regulatory data.
Cross-Functional Collaboration
- Work closely with teams from regulatory affairs, supply chain management, and quality assurance.
- Provide updates on project status and regulatory data activities.
- Coordinate with stakeholders to resolve issues affecting product release timelines.
Risk Escalation and Issue Resolution
- Identify operational risks and escalate issues when necessary.
- Support the resolution of system-related challenges impacting product releases.
- Ensure critical issues are communicated to relevant stakeholders.
Continuous Improvement
- Identify opportunities for improving regulatory data workflows.
- Suggest enhancements for system efficiency and compliance.
- Participate in initiatives aimed at improving operational processes.
Compliance and Quality Standards
- Ensure all tasks comply with Good Manufacturing Practices (GMP) and internal company policies.
- Support compliance with global regulatory standards and data integrity principles.
Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Eligibility Criteria
Education
Candidates must possess a bachelor’s degree in one of the following fields:
- Pharmaceutical Sciences
- Chemistry
- Life Sciences
- Or another closely related scientific discipline
Experience
- Minimum 3 years of experience in regulatory operations, quality compliance, or pharmaceutical technical operations.
- Experience within the biopharmaceutical or pharmaceutical industry is strongly preferred.
- Hands-on exposure to regulatory submission data and manufacturing information management is advantageous.
Skills Required
Candidates applying for this role should demonstrate strong technical and analytical skills related to pharmaceutical regulatory data. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Technical Skills
- Knowledge of regulatory submission lifecycle management
- Familiarity with SAP systems in pharmaceutical manufacturing environments
- Experience with Veeva Vault RIM or Veeva Quality Systems
- Understanding of electronic quality management systems (eQMS)
- Knowledge of Bills of Materials (BOM) within pharmaceutical supply chains
Regulatory Knowledge
- Understanding of global regulatory submission processes
- Knowledge of post-approval regulatory changes and renewals
- Familiarity with eCTD submission formats and CTD Module 3 documentation
Compliance Knowledge
- Awareness of 21 CFR Part 11 regulations
- Understanding of EU Annex 11 requirements
- Knowledge of data integrity standards in regulated environments
Soft Skills
- Excellent analytical and problem-solving abilities
- Strong communication and documentation skills
- Ability to work in cross-functional teams
- Organizational and project management skills
- Ability to handle complex data management tasks efficiently
Salary & Benefits
Salary and compensation will be offered as per company norms and experience level.
Employees may also receive access to company benefits programs, professional development opportunities, and global career growth prospects. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Selection Process
The recruitment process generally involves multiple evaluation stages:
- Online application screening
- HR or recruiter discussion
- Technical interview with department specialists
- Final managerial interview
- Offer and onboarding process
Selection procedures may vary depending on the hiring team’s requirements. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
How to Apply
Interested candidates should apply through the official company careers portal by submitting an online application for the Senior Specialist – APMC Data Management position.
Applicants are advised to ensure their resumes highlight relevant experience in regulatory systems, pharmaceutical operations, and quality compliance. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Important Dates
- Application Deadline: Not specified (applications may close once positions are filled)
Early application is recommended to increase the chances of consideration. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Why Apply for This Pharma Job?
This role provides an excellent opportunity for professionals who want to build a career in regulatory operations and pharmaceutical data management within a global biopharmaceutical company. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Key advantages include:
- Exposure to global regulatory systems and digital platforms
- Opportunity to work with international regulatory and supply chain teams
- Experience with industry-leading tools such as Veeva and SAP
- Career growth within a multinational pharmaceutical organization
- Participation in innovative projects supporting biologics and advanced therapies
Professionals interested in regulatory compliance, digital regulatory systems, and pharmaceutical manufacturing operations will find this position valuable for long-term career development.
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares career opportunities in the pharmaceutical, biotechnology, and healthcare sectors.
We are not affiliated with Bristol Myers Squibb or any other company mentioned in this job post. Candidates are advised to apply only through the official company career portal and verify all details before submitting their application. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
Final Call to Action
Candidates with experience in pharmaceutical regulatory systems, quality compliance, and supply chain data management are encouraged to apply for this opportunity and advance their careers in the biopharmaceutical industry. Senior Specialist APMC Data Management Job at Bristol Myers Squibb
