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The demand for Regulatory Affairs and digital transformation roles in pharma is rapidly growing, and this Regulatory Digitization Specialist job in Bangalore offers a strong entry into high-impact regulatory technology and data-driven healthcare operations.
This role focuses on Regulatory Information Management Systems (RIMS), regulatory data quality, and digital process improvement, making it ideal for candidates looking to build a future-proof career in Regulatory Affairs, RIMS, and pharma digitalization.
If you have experience in regulatory operations, QMS, data management, or system-driven workflows, this opportunity aligns perfectly with current industry trends toward AI-driven regulatory systems and compliance automation.
Key Responsibilities – Regulatory Digitization Role
Regulatory Data & RIMS Management
- Support Regulatory Information Management System (RIMS) activities
- Review and audit regulatory data for quality gaps and inconsistencies
- Maintain regulatory documents, certificates, and structured data
- Generate and analyze RIMS reports for business insights
System Administration & Digital Support
- Manage user roles, workflows, and system configurations
- Understand enterprise systems like QMS, document management, ERP
- Support validation and optimization of regulatory digital platforms
Process Documentation & Compliance
- Ensure alignment with QMS procedures and regulatory standards
- Prepare documentation for data migration and validation
- Assist in updating SOPs and regulatory workflows
System Integration & Stakeholder Collaboration
- Work with Regulatory Affairs, QA, IT, Supply Chain teams
- Support system integration initiatives for better data flow and compliance
- Promote adoption of digital regulatory processes
Vendor Coordination
- Participate in vendor discussions and track deliverables
- Monitor vendor performance and support issue resolution
Qualifications & Skills Required
Educational Background
- B.Pharm / M.Pharm / MSc / Life Sciences / Biotechnology / related field
Technical Skills
- Knowledge of Regulatory Affairs, RIMS, or regulatory documentation
- Understanding of QMS-controlled environments
- Experience with data analysis, structured datasets, and validation
- Familiarity with RIMS platforms or enterprise systems (preferred)
Soft Skills
- Strong analytical and problem-solving ability
- High attention to detail (critical for regulatory compliance)
- Excellent communication and stakeholder management
- Ability to handle multi-functional collaboration in pharma environments
Preferred Experience
- Experience in Regulatory Affairs / Regulatory Operations / QA systems
- Exposure to RIMS, QMS, data migration, validation documentation
- Background in pharmaceutical, medical devices, or CRO industry
- Experience working with vendors and cross-functional teams
Salary (Estimated Range in India)
- ₹5.5 LPA – ₹10 LPA (based on experience and skillset)
Benefits of This Role
- Exposure to Regulatory Digital Transformation & AI-driven systems
- Career growth in RIMS, Regulatory Affairs, and Pharma IT
- Cross-functional experience across QA, IT, Regulatory, Supply Chain
- Opportunity to work in global regulatory compliance environments
How to Apply
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