Associate - CSCC & RM

Abbott; Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Abbott in Mumbai seeks an experienced Associate for Registration Management & CSCC to ensure accurate regulatory data and timely submissions. You will manage RIM systems, track global submissions, and work with Regulatory Affairs, Pharmacovigilance, and affiliates to maintain high data quality and transparency.

The role emphasizes system enhancements, testing, validation, and robust governance practices, supporting audit readiness and data standards across the organization.

Qualifications

• Science background required.
• 2–5 years of experience in regulatory data management.
• Experience with EMA XEVMPD or similar is a plus.

Responsibilities

• 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.

Skills

RIM systems

Regulatory data management

Education

Science background

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