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Regulatory Affairs Specialist Job at Baxter

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Apply for Specialist Regulatory Affairs at Baxter 2026. Check eligibility, responsibilities, pharmacovigilance tasks, and last date to apply now.

Introduction

If you are looking to grow your career in Regulatory Affairs and pharmacovigilance, this opportunity offers strong exposure to global safety reporting and compliance processes. The Specialist Regulatory Affairs at Baxter role is ideal for candidates interested in working on aggregate safety reports, risk management plans, and regulatory submissions. This position provides hands-on experience in international regulatory frameworks and drug safety operations.


Job Overview

Job TitleSpecialist โ€“ Regulatory Affairs (RA)
Company NameBaxter
LocationAhmedabad, Gujarat
Employment TypeFull-Time
DepartmentRegulatory Affairs / Pharmacovigilance
Experience RequiredRelevant experience required
EducationLife Sciences / Pharmacy (preferred)
SalaryAs per company standards

Company Overview

Baxter is a global healthcare company committed to improving patient outcomes through innovative medical products and therapies. Founded in 1931, the company operates worldwide and focuses on delivering life-saving treatments. Baxter promotes a culture of collaboration, innovation, and accountability, offering employees opportunities to make a meaningful impact in healthcare.


Job Location & Employment Type

This is a full-time position based in Ahmedabad, Gujarat. The role involves working with global regulatory and pharmacovigilance teams.


Open Positions / Department Details

The role is part of the Regulatory Affairs and Pharmacovigilance team. The selected candidate will support safety reporting, regulatory submissions, and compliance activities across global markets.


Key Roles & Responsibilities

Aggregate Safety Reporting

  • Prepare and review PSUR, PBRER, and PADER reports
  • Support pharmacovigilance activities for new submissions and post-approval processes
  • Handle regulatory queries and ensure timely submission of reports
  • Coordinate with internal teams for safety data compilation
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Risk Management Plan (RMP) Activities

  • Assist in development and submission of Risk Management Plans
  • Coordinate with global and internal regulatory teams
  • Ensure timely submission as per regulatory requirements

CO / NCO Activities

  • Support development and submission of CO/NCO documentation
  • Collaborate with global teams for compliance and timelines

Signal Management

  • Manage safety signal evaluation and updates
  • Perform CCDS, CCSI, and RSI updates based on safety data
  • Support periodic safety reviews and label updates

Database & Compliance Activities

  • Maintain XEVMPD database and ensure accurate data updates
  • Monitor EV codes and manage new code generation
  • Perform global label monitoring using systems like Fluxguard

Eligibility Criteria

Education

  • Degree in Pharmacy or Life Sciences

Experience

  • Relevant experience in regulatory affairs or pharmacovigilance preferred

Skills Required

  • Knowledge of pharmacovigilance and safety reporting (PSUR, PBRER, PADER)
  • Understanding of global regulatory requirements
  • Familiarity with RMP, signal management, and labeling updates
  • Strong analytical and documentation skills
  • Ability to manage timelines and multiple tasks
  • Good communication and teamwork skills

Salary & Benefits

  • Salary: As per company standards
  • Opportunity to work with a global healthcare leader
  • Exposure to international regulatory and safety processes
  • Career growth in regulatory affairs and pharmacovigilance
  • Collaborative and professional work environment

Selection Process

The selection process may include:

  • Resume screening
  • Technical interview (Regulatory Affairs & PV concepts)
  • HR discussion

How to Apply

Interested candidates can apply online through the official Baxter careers portal using the job requisition ID provided in the listing.


Important Dates

  • Last Date to Apply: April 23, 2026

Why Apply for This Job?

This role provides excellent exposure to global regulatory affairs and pharmacovigilance activities. Candidates will gain hands-on experience in safety reporting, risk management, and regulatory compliance, which are critical areas in the pharmaceutical industry. Working at Baxter enhances your professional profile and opens opportunities for advanced roles in global regulatory operations.

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FAQs

1. Who can apply for this job?
Candidates with a Pharmacy or Life Sciences background and relevant experience can apply.

2. What is the job location?
The job is based in Ahmedabad, Gujarat.

3. What is the last date to apply?
The last date is April 23, 2026.

4. What key skills are required?
Knowledge of pharmacovigilance, regulatory reporting, and safety data management is required.

5. How can I apply for this job?
You can apply through the official Baxter careers portal.


Conclusion

The Specialist Regulatory Affairs at Baxter is a strong opportunity for professionals aiming to grow in regulatory and pharmacovigilance domains. With global exposure and hands-on experience in safety reporting and compliance, this role can significantly boost your career in the pharmaceutical industry. Apply before the deadline to secure your chance.


Disclaimer

PharmaJobHub.in is an independent job information platform. We do not provide jobs or recruitment and are not affiliated with any company.


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