Makro Group is actively hiring for Regulatory Affairs and Clinical Quality Assurance (CQA) roles in Hyderabad. This is a strong opportunity for life sciences candidates looking to build careers in regulatory intelligence, clinical trials, and quality compliance (ICH-GCP & ISO) within a growing CRO environment.

---

📌 Open Positions

1️⃣ Research Analyst-II (Regulatory Affairs)

• Experience: 1–3 Years
• Domain: Regulatory Affairs / Clinical Research

2️⃣ Clinical Quality Assurance (CQA) Associate

• Experience: 2–3 Years
• Domain: Clinical Quality / Audits / QMS

---

🧾 Key Responsibilities

🔹 Regulatory Affairs Role

• Conduct secondary research on drugs, devices & clinical trials
• Analyze global regulatory requirements & impact
• Extract insights from clinical trial data, SEC filings, NIH reports
• Track pharma pipeline and regulatory updates
• Compile scientific intelligence reports

🔹 CQA Role

• Maintain and review SOPs and QMS documentation
• Conduct internal audits (ICH-GCP, ISO compliance)
• Manage CAPA, deviations, change controls
• Support external audits & regulatory inspections
• Maintain training records and compliance logs

---

🎓 Qualifications

• UG/PG in Life Sciences (B.Pharm, M.Pharm, BSc, MSc)
• Strong knowledge of:
  • Regulatory Affairs & Clinical Trials
  • ICH-GCP Guidelines
  • ISO Standards & QMS
  • Scientific terminology & documentation
• Experience in RA, QA, or Clinical Research preferred

---

💼 Benefits

• Work in a global regulatory & clinical research environment
• Exposure to real-world regulatory intelligence & audits
• Career growth in RA, QA, and CRO domains
• Collaborative and learning-driven workplace

---

📩 Application Process

Application Link For Research Analyst-II (Regulatory Affairs)

Application Link For Clinical Quality Assurance (CQA) Associate