Associate - CSCC & RM

Abbott; Mumbai City; On-site; INR 600,000 - 900,000; Full time

Job summary

Abbott in Mumbai, India seeks an Associate for Registration Management & CSCC to support regulatory data in RIM systems and coordinate global submissions. You will work with Regulatory Affairs, Pharmacovigilance, and affiliates to keep data accurate and transparent.

Responsibilities include system enhancements, testing, UAT, and ensuring timely regulatory data submissions including EMA XEVMPD. 2–5 years of experience and a science background are preferred, with on-site Mumbai location.

Qualifications

• 2–5 years of experience in regulatory operations or related field.
• Science background required.
• Experience with regulatory data management is a plus.

Responsibilities

• Support and administer Regulatory Information Management (RIM) systems to ensure accurate regulatory data.
• Track global regulatory submissions, approvals, and product lifecycle activities in the RIM platform.
• Collaborate with Regulatory Affairs, Pharmacovigilance, affiliates and cross-functional teams to maintain data quality.
• Assist with audits, inspections readiness, documentation, and reporting.
• Support data standards, governance, and timely regulatory data submissions.

Education

Science Background

Tools

RIM systems

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)