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Associate - CSCC & RM
Mumbai, Maharashtra
Full-time

Job details

Pay information not provided
Full-time
Mumbai, Maharashtra

Full 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

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