Ensure the on-time filing of high-quality regulatory labeling submissions and to assist in the preparation, maintenance, and control of regulatory Dossiers (labeling part).
Interact with all levels in the organization, and across several functions particularly Compliance, Marketing, R&D;, engineering (packaging), manufacturing and QA/QC.
Participate in discussions to provide strategic regulatory guidance to team members in India and other Region operations.
Interact with regulatory agencies on regulatory submissions and follow ups of drug products.
Oversee the preparation and filing of high-quality labeling submissions to regulatory authorities.
Ensure that all applications are filed in accordance with regulations and requirements.
Provide regulatory guidance to staff and inter-disciplinary project teams.
Be a proactive member of the Regulatory team to ensure Baxter's continuing compliance with regulatory authorities.
Continue to develop quality standards and procedures for RA.
Facilitate product labeling development/Launch activities for respective Markets.
SPL preparation and Drug listing activity for USA products.
Maintain query/variation labeling database.

📌 Spec, Ra Labelling Ahmedabad (India)
🏢 Baxter India
📍 India