Associate - CSCC & RM

Thornton Tomasetti; Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Abbott in Mumbai seeks a Regulatory Operations professional to support and administer Regulatory Information Management (RIM) systems, ensuring accurate and compliant regulatory data across global submissions. You will track submissions, manage lifecycle activities, coordinate with Regulatory Affairs, Pharmacovigilance, and affiliates, and help with audits, data standards, governance, and reporting.

With 2–5 years in a science background, you will contribute to data integrity, KPI reporting,

Qualifications

• Years of experience: 2-5 years.
• Education: Science background.

Responsibilities

• Support and administer Regulatory Information Management (RIM) systems to ensure accurate, compliant regulatory data.
• Track global regulatory submissions, approvals, commitments, and product lifecycle activities within the RIM platform.
• Coordinate 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).
• Assist with regulatory compliance activities, including audit/inspection readiness, documentation, and reporting.

Education

Science Background

Job description

JOB DESCRIPTION

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 & Education

Years of Experience - 2 - 5years Education - Science Background

Pay & Location

The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

Job Family, Division, Location, Shift

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)

Company Overview

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

Work Environment

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

Equal Opportunity

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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