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ID de la oferta JR - 133135 Ubicación Ahmedabad, State of Gujarāt, India Categoría de Trabajo Regulatory Affairs Fecha de publicación 04/19/2024

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.

  • Coordinate with Manager for the product details to initiate the labeling preparation for new dossier or labeling query response or any routine changes in the artworks during commercial mfg. or during variation submission.
  • Initiate the request in SAP and follow Harmony software for artworks finalization work flow.
  • Final release of the artworks for commercialization.
  • Any updation in the labelling content of the artworks to make it in line as per RLD.
  • Co-ordinate with respective department to clear the artwork in work flow.
  • Monitor the safety related changes on authority website, communicate to global team and accordingly initiate the artwork revision.
  • To assist superior for Pharmacovigilance related activities
  • Be a proactive member of the Regulatory team to ensure Baxter's continuing compliance with FDA and other regulatory authorities.
  • Maintain the data base of pharmacovigilance activity, safety — signal changes related database and communicate to global team accordingly.
  • Continue to develop quality standards and procedures for RA. Internally support in RIM/TcU for artworks related activities.

You will also be responsible for any other work, which may be assigned to you by the management from time to time.

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.


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