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)