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)