Job title: Regulatory affairs specialist(baxter)

Roles and Responsibilities

Ensure the on-time filing of high-quality regulatory submissions, and to assist in the preparation, maintenance, and control of regulatory Dossiers.

• Interact with all levels in the organization, and across several functions particularly Compliance, Marketing, R&D, engineering, manufacturing, and QA/QC.

• Participate in discussions to provide strategic regulatory guidance to team members in India and other Region operations.

• Interact with regulatory agency on regulatory submissions and follow ups of drug products.

• Oversee the preparation and filing of high-quality 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 development/Launch activities for respective Markets.