Job Description Summary
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape

Provide effective operational and regulatory support to ensure compliance and regulatory submission activities for ANZ, effective regulatory reporting on submission, HA questions and approval status and follow on activities including continuous improvement in relation to standards, templates and pro-cedures. Regulatory Information Management (RIM) on relevant systems, trackers and databases for regula-tory submissions and commitments.
Support the team with life cycle management and registration information support for the Australia and Recent Zealand market to allow the best possible time frame for registration and launch/supply continuity.

Job Description
Major Accountabilities

1. Operational Efficiency




• Maintain high quality data management on regulatory submission information supported in line with priority and portfolio plan in partnership with Regulatory Affairs team. Accountable for accurate and timely entries into various local and global databases and tracking platforms to ensure compliance and knowledge management through Regulatory Information Management (RIM), reporting, tracking of ANZ submission, approval status and post-approval commitments.
• Ensure key submission and post approval activity data provided by RA is up to date and accurate. Ongoing review of tracking metrics to identify areas of improvement. Oversight of training and management of local Standard Operating Procedures (SOP) and Working Procedures (WP) for currency and effectiveness to ensure RA operations remain optimal and ensure compliance to support business objectives.
• Assist in the review and maintenance of local WPs and SOPs to refine

📌 Regulatory Affairs Specialist – Submission Info Management (India)
🏢 Sandoz
📍 India