• Work document formatting as part of authoring support group (ASG),review, compilation, publishing for Devices & Drugs Submissions
• Submission Life Cycle Management for Devices & Drugs to be able to process eCTD / NeeS/ paper submissions for global markets.
• Should have experience in DXC publishing suite.
• Should have worked in Veeva Vault for publishing related activities.
• Will have to work independently with minimal support.
• Will be co-located with the current Publishing team in Bengaluru, India
• Will work with global regulatory leads (GRLs) across the Globe for Drugs and Devices
• NO direct interaction with Health Authorities but will have access to client's health authority gateways for submission dispatch.

 

XEVMPD Data Management & Compliance:
• Ensure accurate and timely XEVMPD data submissions per EMA requirements.
• Maintain compliance with evolving EMA regulations and implement necessary updates.
• Perform quality control (QC) checks to ensure data integrity and consistency.
• Liaise with regulatory agencies for submission queries and compliance requirements.
• Support the transition from XEVMPD to IDMP by aligning data structures and regulatory requirements.
• Collaborate with regulatory teams to implement IDMP-related changes in the RIM system.
• Assist in data mapping, validation, and cleansing to ensure IDMP readiness.
• Should have worked in Veeva Vault on xEVMPD objects.