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
