Associate, Regulatory Operations Data Management

Support the preparation of Module 1 administrative documents such as cover letters, application forms, notification forms, and comparison tables.

Create submission packages aligned with regulatory strategies for pharmaceuticals, biologics, vaccines, generics, and other regulated products.

Perform quality checks and technical validation of submission packages to ensure compliance with regional Health Authority requirements.

Manage and maintain regulatory information in Regulatory Information Management (RIM) systems and document management repositories.

Create, review, update, and maintain regulatory data, including product registrations, submission records, Health Authority interactions, licenses, commitments, and approval information.

Ensure accuracy, completeness, and consistency of regulatory data across systems, dossiers, and regulatory databases.

Support data migration, data cleanup, governance activities, and process improvements within regulatory systems.

Generate regulatory reports, metrics, dashboards, and submission status updates to support decision-making and compliance tracking.

Track submission milestones, maintain regulatory trackers, and monitor timelines to ensure timely execution of regulatory commitments.

Collaborate with Regulatory Affairs, R&D, Quality, Manufacturing, Clinical, and Supply Chain teams to gather, review, and manage submission-related documentation and data.

Conduct regulatory intelligence activities by monitoring evolving global regulations, submission requirements, and industry trends.

Support post-approval lifecycle management activities, including variations, renewals, annual reports, registrations, and product maintenance.

Utilize regulatory publishing tools, document management systems, and regulatory databases to manage end-to-end submission processes.

Participate in process improvement initiatives, inspections readiness activities, SOP compliance, and knowledge-sharing programs.

Continuously develop expertise in global regulatory requirements, regulatory operations, publishing technologies, and regulatory data management practices.

Knowledge of Docubridge tool

Minimum 7 years of experience in Regulatory Affairs