Looking to advance your career in Regulatory Affairs, ICSR processing, and Aggregate Reporting? Synapmed is hiring a Regulatory Affairs Associate – ICSR & Aggregate Reporting for its Bengaluru operations (Remote role).
This opportunity is ideal for professionals with 3–5 years of experience in Regulatory Affairs, pharmacovigilance submissions, global regulatory documentation, and clinical trial regulatory processes.
If you have hands-on experience in ICSR submissions, Aggregate Reports, CCDS, USPI, SmPC, and Regulatory Intelligence reporting, this role offers strong exposure to global regulatory frameworks.
📌 Job Overview
- Position: Regulatory Affairs Associate – ICSR & Aggregate Reporting
- Experience Required: 3–5 Years
- Job Type: Full-time
- Location: Bengaluru, Karnataka (Remote)
🧾 Key Responsibilities
The selected candidate will be responsible for:
- Preparing and managing ICSR (Individual Case Safety Reports) submissions.
- Handling Aggregate Reports (PSUR/PBRER/DSUR).
- Reviewing and maintaining CCDS, USPI, SmPC, and safety documentation.
- Compiling and submitting monthly Regulatory Intelligence reports.
- Coordinating with Health Authorities for regulatory communications.
- Supporting Clinical Trial (CT) regulatory processes.
- Ensuring compliance with global regulatory guidelines (ICH, USFDA, EMA, MHRA, etc.).
- Maintaining accurate documentation aligned with submission standards.
🎓 Qualifications & Eligibility
To apply for this Regulatory Affairs Associate position, candidates should have:
- 3–5 years of relevant experience in Regulatory Affairs or Pharmacovigilance.
- Hands-on experience in:
- ICSR submissions
- Aggregate Reporting
- CCDS / USPI / SmPC preparation
- Strong understanding of:
- Global regulatory submission formats
- International guidelines (ICH, GVP modules)
- Excellent documentation and communication skills.
- Experience in clinical trial regulatory support is preferred.
💼 Why This Role is Important
With increasing global scrutiny on drug safety and aggregate reporting compliance, Regulatory Affairs professionals play a crucial role in:
- Ensuring patient safety through accurate ICSR reporting.
- Maintaining global labeling consistency (CCDS, SmPC, USPI).
- Supporting timely submissions to regulatory agencies.
- Strengthening pharmacovigilance systems.
This Regulatory Affairs Associate role provides direct exposure to international submission standards and global safety reporting frameworks.
💰 Salary & Benefits
- Estimated Salary Range: ₹5.5 – ₹8.5 LPA (based on experience and industry standards)
- Remote working flexibility
- Exposure to global regulatory processes
- Growth in Aggregate Reporting and Pharmacovigilance documentation
- Opportunity to work in a structured regulatory environment
📥 How to Apply
