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)