Global healthcare leader Baxter has announced an exciting opportunity for professionals in Regulatory Affairs and Pharmacovigilance. The company is hiring a Specialist, Regulatory Affairs (RA) for its Ahmedabad, Gujarat location. Candidates with experience in Aggregate Safety Reports, Risk Management Plans (RMP), Signal Management, Pharmacovigilance, and Regulatory Compliance are encouraged to apply.

This Baxter Regulatory Affairs job offers an excellent opportunity to work on global pharmaceutical regulatory submissions, safety reporting, risk management activities, and post-marketing surveillance programs while contributing to Baxter’s mission of saving and sustaining lives.

About Baxter

Baxter is a globally recognized healthcare company dedicated to improving patient outcomes through innovative medicines, medical devices, and healthcare solutions. Founded in 1931, Baxter operates across multiple countries and serves millions of patients worldwide.

The company promotes a culture of innovation, collaboration, accountability, and professional growth while maintaining the highest standards of patient safety and regulatory compliance.

Job Details

Key Responsibilities

Aggregate Safety Report Activities

The selected candidate will be responsible for:

• Supporting Pharmacovigilance activities for new submissions and post-approval products.
• Reviewing and preparing PSUR, PBRER, and PADER reports.
• Managing Aggregate Safety Governance (ASG) authoring support activities.
• Coordinating safety report submissions according to regulatory timelines.
• Handling requests from global and local Regulatory Affairs and Pharmacovigilance teams.

Risk Management Plan (RMP) Activities

• Assist in development and maintenance of Risk Management Plans.
• Coordinate with global RMP teams and internal regulatory teams.
• Ensure timely submission of RMP documentation.

CO/NCO Activities

• Support preparation and submission of CO/NCO documentation.
• Coordinate activities with global regulatory stakeholders.
• Monitor regulatory timelines and compliance requirements.

Signal Management Activities

• Identification and management of new Reference Safety Information (RSI).
• Development and revision of CCDS and CCSI documents.
• Conduct periodic CCDS and CCSI reviews.
• Support local label updates based on safety signal evaluations.

XEVMPD Activities

• Maintain Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) database.
• Monitor EV code updates and approvals.
• Generate new EV codes for approved products.
• Support global label monitoring through Fluxguard systems.

Preferred Qualifications

Candidates with the following background may be preferred:

• B.Pharm
• M.Pharm
• Pharm.D
• M.Sc Life Sciences
• Other relevant Life Sciences qualifications

Required Skills

• Regulatory Affairs
• Pharmacovigilance
• PSUR Preparation
• PBRER Authoring
• PADER Reporting
• Risk Management Plans (RMP)
• Signal Detection and Signal Management
• CCDS / CCSI Management
• XEVMPD Database Management
• Drug Safety Compliance
• Global Regulatory Submissions
• Labeling Compliance
• Safety Data Analysis

Why Join Baxter?

Working at Baxter provides professionals with opportunities to:

• Collaborate with global regulatory and safety teams.
• Gain exposure to international pharmacovigilance regulations.
• Work on critical patient safety initiatives.
• Enhance expertise in aggregate safety reporting and signal management.
• Build a long-term career with a leading multinational healthcare company.

Salary Expectations

Based on current Regulatory Affairs and Pharmacovigilance market trends in India, the estimated annual salary for this role is:

₹8,00,000 – ₹15,00,000 per annum

Actual compensation may vary depending on qualifications, experience, and Baxter’s internal compensation structure.

How to Apply

Application Link