Senior Executive

About the role

To prepare, review and submit dossiers for Life cycle management, and other submissions as required for EU region. Preparation, review and submission of eCTD Renewal, variations, post marketing applications and other related activities. Timely initiation and follow-ups with cross functions for necessary document support for preparation and submission of new/Query response etc.

What you'll do

• Prepare, review and submit dossiers for Life cycle management, and other submissions as required for EU region
• Review and approve SAP orders and technical documents from cross functions related to
• Prepare/update project trackers related to variations with defined action points and target timelines
• Maintain appropriate archival of submission related documents
• Attend and represent my supervisor in required technical meetings with main Cross functions for any

What you need

• Regulatory affairs
• SAP
• Any graduate