Together, we create a place where we are happy, successful, and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Job Description:
- Ensure the on-time filing of high-quality regulatory submissions.
- 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 agencies 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 Regulatory Affairs.
- Facilitate product development/launch activities for respective markets.
