Associate - CSCC & RM

Job description

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)