Associate - Cscc & Rm

**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/A In 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)