Manager - Registration Management
1758 abbott healthcare private
📍 india mumbai mumbai development center - epd india🕐 1mo ago🔗 workday
Job Description
**JOB DESCRIPTION:**
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**Role Purpose**
Provide strategic and operational leadership for Regulatory Information Management (RIMs) to ensure accurate, compliant, and timely management of global regulatory data, product lifecycle activities, and inspection readiness.
**Key Responsibilities**
* Lead and develop a high‑performing RIMs team to deliver seamless day‑to‑day regulatory operations.
* Oversee creation and maintenance of regulatory applications for NPIs, safety variations, and lifecycle activities.
* Provide subject‑matter expertise and operational support for regulatory activities managed within centralized RIMs systems.
* Manage workflows for timely delivery of critical regulatory reports (e.g., Status, Product Quality, WWMAS) supporting supply, manufacturing, PV inspections, and governance.
* Own XeVMPD submissions and ongoing maintenance of registered product data.
* Ensure accuracy, integrity, and completeness of registered product and master data across global markets (LATAM, METAP, APAC, EU, India, and others).
* Maintain and update SOPs and Work Instructions for assigned workstreams, ensuring continuous audit and inspection readiness.
* Support regulatory audits and health authority inspections through RIMs expertise, data extraction, and documentation.
* Lead User Acceptance Testing (UAT) and related testing for new features, system enhancements, or major RIMs implementations.
* Drive continuous improvement, data quality excellence, and compliance with global regulatory requirements.
* Manage team performance, capability building, and career development.
**Required Expertise**
* Strong knowledge of global regulatory regulations and guidelines.
* Hands‑on experience with industry‑standard RIMs tools and regulatory systems.
* Proven people leadership and stakeholder management capability.
**The base pay for this position is**
N/A
In specific locations, the pay range may vary from the range posted.
**JOB FAMILY:**
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Regulatory Operations
**DIVISION:**
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EPD Established Pharma
**LOCATION:**
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India > Mumbai : Mumbai Development Center - EPD
**ADDITIONAL LOCATIONS:**
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**WORK SHIFT:**
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Standard
**TRAVEL:**
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Not specified
**MEDICAL SURVEILLANCE:**
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Not Applicable
**SIGNIFICANT WORK ACTIVITIES:**
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Not Applicable