Senior Specialist – RIM & DO
📍 Location: Bengaluru, India
🏢 Category: Regulatory
🆔 Job ID: 428473
📅 Posted Date: October 8, 2025
Job Purpose / Overview
The Senior Specialist – RIM & DO provides subject matter expertise in Regulatory Information Management (RIM) systems and processes within Global Regulatory Affairs (GRA). This role ensures accurate regulatory data management, supports end users, monitors data quality, and drives continuous process and system improvements to facilitate efficient regulatory operations.
Key Responsibilities
Regulatory Information Management & Data Maintenance
Serve as SME in RIM systems, including Regulatory Vault and legacy systems.
Create and maintain regulatory information to support GRA submission activities, often on urgent timelines.
Complete complex or non-routine data maintenance tasks accurately and on schedule.
Ensure adherence to data standards and defined procedures for self and junior colleagues.
Maintain System Reference Data following approved procedures.
End-User Support & Training
Provide primary support to RIM system users: guidance, ad hoc training, reports, and attendance at meetings.
Act as RIM Subject Matter Expert, partnering with GRA Process Leads to support continuous improvement.
Mentor and support new starters and junior colleagues.
Data Quality & Analysis
Routinely monitor data quality, conduct root cause and trend analyses.
Identify and implement corrective and preventive actions.
Perform routine/ad hoc data extraction and transformation for KPI generation and performance monitoring.
System & Process Improvement
Support system validation activities, including User Acceptance Testing and Change Control assessments.
Maintain procedural documentation: SOPs, WIs, How-to Guides, user manuals, and handbooks.
Promote a continuous improvement culture within the team, proposing and supporting system/process changes.
Streamline communication of regulatory information to Manufacturing and QA Release stakeholders.
Basic Qualifications
6–8 years of experience in data or records management.
Proven ability to complete data management tasks accurately across a broad range of procedures.
Preferred / Related Experience
Knowledge of Registration Information Management (RIM) roles and responsibilities.
Familiarity with submission formats, content navigation, and health authority regulations.
Awareness of records retention procedures and regulatory document management practices.
Strong analytical skills for working with large datasets.
Excellent interpersonal, organizational, and prioritization skills.
Familiarity with GSK processes, marketed and investigational products, and IT systems, including RIM tools.
Ability to deliver high-quality output under regulatory deadlines.
Strong written and verbal communication skills.
Why GSK?
Mission: Unite science, technology, and talent to get ahead of disease.
Impact Goal: Positively impact the health of 2.5 billion people by decade-end.
Focus Areas: Respiratory, Immunology & Inflammation, Oncology, HIV, Infectious Diseases.
Culture: Ambitious for patients, accountable for impact, and committed to doing the right thing.
Inclusion & Accessibility
Candidates can request accommodations during the recruitment process.
Contact: IN.recruitment-adjustments@gsk.com
Employment Agency & Legal Notices
GSK does not accept unsolicited agency referrals without prior authorization.
Beware of fraudulent postings requesting payments; GSK does not charge fees.
Verify suspicious communications via askus@gsk.com.
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