BABaxter India Pvt Ltd
Spec, RA - Labelling
Ahmedabad ₹2-6 LPA Posted 10 Apr 2025
FULL TIME
Compliance
r&d
Job Description
- Ensure the on-time filing of high-quality regulatory labeling submissions and to assist in the preparation, maintenance, and control of regulatory Dossiers (labeling part).
- Interact with all levels in the organization, and across several functions particularly Compliance, Marketing, R&D, engineering (packaging), 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 labeling 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 labeling development/Launch activities for respective Markets.
- SPL preparation and Drug listing activity for USA products.
- Maintain query/variation labeling database.