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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/AIn 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)

📌 Associate - CSCC & RM (Mumbai)
🏢 Abbott
📍 Mumbai