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Looking to build a strong career in Regulatory Affairs (RA) and Pharmacovigilance (PV)? Hereโs a high-impact opportunity with a global healthcare leader. Baxter is hiring a Specialist โ Regulatory Affairs (RA) in Ahmedabad, Gujarat, offering exposure to global safety reporting, RMP, signal management, and regulatory compliance.
This role is ideal for candidates with experience in PSUR, PBRER, PADER, RMP, and EudraVigilance, aiming to work on global submissions and lifecycle management.
Job Overview
- Job Title: Specialist, Regulatory Affairs (RA)
- Company: Baxter
- Location: Ahmedabad, Gujarat, India
- Job Type: Full-time
- Job ID: JR – 199698
- Date Posted: April 16, 2026
- Last Date to Apply: April 23, 2026
Key Responsibilities
Pharmacovigilance & Aggregate Reports
- Prepare and review PSUR, PBRER, and PADER reports
- Support post-approval regulatory submissions
- Handle RFI evaluation and authoring support
- Ensure timely submission and coordination with global teams
Risk Management Plan (RMP)
- Assist in development and submission of RMP documents
- Coordinate with global and local regulatory teams
- Ensure compliance with submission timelines
CO/NCO Activities
- Support development of CO/NCO documentation
- Collaborate with global stakeholders for timely submissions
Signal Management
- Manage CCDS, CCSI, and RSI updates
- Conduct periodic safety reviews
- Implement local label updates based on safety signals
XEVMPD & Compliance
- Maintain XEVMPD database
- Monitor EV codes and product updates
- Support global label monitoring (Fluxguard)
Required Qualifications
- Education: B.Pharm / M.Pharm / PharmD / Life Sciences
- Experience: Typically 2โ6 years in Regulatory Affairs / Pharmacovigilance
- Strong knowledge of:
- PSUR / PBRER / PADER
- RMP & Signal Management
- EudraVigilance (XEVMPD)
- Excellent coordination and documentation skills
- Familiarity with global regulatory guidelines
Salary & Benefits
- Estimated Salary: โน6,00,000 โ โน12,00,000 per annum (based on experience)
- Global exposure in regulatory submissions & safety reporting
- Opportunity to work with a leading healthcare MNC
- Career growth in Regulatory Affairs & Pharmacovigilance
- Collaborative and innovation-driven work culture
Why Join Baxter?
Baxter is a globally recognized healthcare company focused on life-saving innovations. With a strong legacy and mission-driven culture, employees gain exposure to cutting-edge regulatory frameworks and global compliance systems.
How to Apply
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