Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Post : Spec, Regulatory Affairs
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.
Additional Information :
Req # JR - 109962
Location : Ahmedabad, Gujarat, India
Job Category : Regulatory Affairs
End Date : 15th November, 2023
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