Spec, RA - Labelling

This is where you save and sustain lives

At 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.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

• 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.
  
  
  

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here 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. To learn how you can protect yourself, review our Recruitment Fraud Notice.