Spec, RA

Baxter India Pvt Ltd

0 years

1 - 6 Lacs

Ahmedabad Gujarat India

Posted:16 hours ago| Platform: Foundit logo

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Skills Required

r&d QA/QC Compliance

Work Mode

On-site

Job Type

Full Time

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.

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