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Req # JR - 166147 Location Ahmedabad, Gujarat, India Job Category Regulatory Affairs Date posted 03/31/2025
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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.

Aggregate Safety Report (PSUR/PBRER/PADER) related activity

PSUR/PBRER/PADER and ACO scheduling and submission

Review and preparation of PADER/PSUR/PBRER, coordination for their submission as per their applicable dates

Handling of request received from central and local regulatory affairs and PV department with respect of timeline.

RMP Related activities

Assist in developing RMP and allied activities

Coordinate with Global team as well as in-house reg team to ensure RMPs are submitted as per their applicable dates

Clinical Overview/Non-Clinical Overview (CO/NCO) Related activities

Assist in developing CO/NCO and allied activities

Coordinate with Global team as well as in-house reg team to ensure CO/NCOs are submitted as per their applicable dates

Signal management activities

Assist in CCDS/CCSI/RSI revision and issuance activities. Coordinate with reg team to ensure local label updates and managing tracking portal updates. 

Ensure the maintenance of XEVMPD database and coordination with global team

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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Address

Explore this location Navratna Corporate Park
Tower A Ground Floor
Tower B 21st and 22nd Floor
Gujarat- 380058
Gujarat
India
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