Baxter Associate RA Job Vacancy – Apply Now
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Associate RA
Req # JR – 079886
Location Ahmedabad, Gujarat, India
Job Category Regulatory Affairs
Date posted 09/07/2022
Re-Post on : 07/08/22
Ensure the on-time filing of high-quality regulatory labeling submissions for US, Canada and Europe Market
To assist in the preparation, maintenance, and control of regulatory Dossiers (Module-1, labeling part) for US, Canada and Europe Market
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 agency on regulatory submissions and follow ups of drug products for US, Canada and Europe Market
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 for US, Canada and Europe Market
Facilitate product labeling development/Launch activities for respective Markets.
SPL preparation and Drug listing activity for USA products.
Maintain query/variation labeling database for US, Canada and Europe Market
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.
Ensure the on-time filing of high-quality regulatory labeling submissions for US, Canada and Europe Market
To assist in the preparation, maintenance, and control of regulatory Dossiers (Module-1, labeling part) for US, Canada and Europe Market
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 agency on regulatory submissions and follow ups of drug products for US, Canada and Europe Market
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 for US, Canada and Europe Market
Facilitate product labeling development/Launch activities for respective Markets.
SPL preparation and Drug listing activity for USA products.
Maintain query/variation labeling database for US, Canada and Europe Market
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.
