Manager - Registration Management

1758 abbott healthcare private

📍 india mumbai mumbai development center - epd india🕐 1mo ago🔗 workday

Job Description

**JOB DESCRIPTION:** -------------------- **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:** --------------- Regulatory Operations **DIVISION:** ------------- EPD Established Pharma **LOCATION:** ------------- India > Mumbai : Mumbai Development Center - EPD **ADDITIONAL LOCATIONS:** ------------------------- **WORK SHIFT:** --------------- Standard **TRAVEL:** ----------- Not specified **MEDICAL SURVEILLANCE:** ------------------------- Not Applicable **SIGNIFICANT WORK ACTIVITIES:** -------------------------------- Not Applicable
Manager - Registration Management at 1758 abbott healthcare private | MergeJobs