About this role
JOB DESCRIPTION: Associate – Registration Management & CSCC (Certificate and samples coordination center)
• Support and administer Regulatory Information Management (RIM) systems to ensure accurate, compliant, and reliable regulatory data. • Track global regulatory submissions, approvals, commitments, and product lifecycle activities within the RIM platform. • Partner with Regulatory Affairs, Pharmacovigilance, affiliates, and cross-functional teams to maintain data quality and transparency. • Support system enhancements, upgrades, testing, validation, and user acceptance testing (UAT) activities. • Troubleshoot and resolve RIM system and data-related issues to ensure business continuity. • Support the implementation and maintenance of regulatory data standards, processes, and governance practices. • Assist with regulatory compliance activities, including audit/inspection readiness, documentation, and reporting. • Support safety variation submissions by maintaining quality-compliant regulatory records and lifecycle activities in collaboration with affiliates and global teams. • Ensure timely and accurate submission of regulatory data to health authorities and external databases, including EMA XEVMPD. • Coordinate CSCC activities with affiliates, TPMs, and internal stakeholders to obtain Certificates, Module 1 documents, and support legalization requirements. • Maintain tracking records, monitor deliverables, and ensure timely closure of regulatory requests and activities. • Generate and maintain monthly KPIs and compliance metrics to support operational performance and management reporting. • Contribute to continuous improvement initiatives that enhance regulatory efficiency, data integrity, and compliance. Years of Experience - 2 - 5years Education - Science Background
The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: EPD Established Pharma LOCATION: India > Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)