Manager - Registration Management

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:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)