Major Accountabilities

• 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 processes and procedures in accordance with global SOPs.



Assist the Regulatory Affairs Department in the development and collation of dossier including processes and procedures to deliver high-quality published submissions to meet HA requirements for an effective submission.
• Ensure systems and processes are in place to enable regulatory history for all applications is traceable and regulatory documents are easy to locate. Evaluates proposed changes and provides functional input and update for affiliate regulatory actions and impact.
• Contributes to performance tracking and KPIs of the team to deliver agreed targets and objectives and supports reporting. Provide regular reports for compliance status for variations and life cycle projects and risk to the business in terms of supply continuity, process improvement.
• Liaison with international parent and license companies, third parties for the acquisition of documentation, information and responses to issues raised during review/evaluation. Create and

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