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Spec, RA

Spec, RA

ConfidentialAhmedabad
30+ days ago
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.

    • Skills Required

    r&d, Compliance

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    Spec Ra • Ahmedabad