Associate - CSCC & RM
Bioksha
- 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.
Education - Science Background