BA
Job Description
- 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.