The pharmaceutical industry is evolving fast, and precision in regulatory compliance has never been more critical. We are hiring an Officer – Regulatory Affairs (RA) for a growing pharmaceutical organization based in Navi Mumbai.
If you thrive on global regulatory challenges and have hands-on experience with EU & US market submissions, this role could be your next career leap 💊🌍
🔍 Role Overview & Impact
As a Regulatory Affairs Officer, you will play a key role in bridging pharmaceutical innovation with international market approvals. Your work will directly support compliance with USFDA and EMA regulations, ensuring high-quality, timely regulatory submissions.
📝 Key Responsibilities
- Dossier Preparation & Submissions:
Prepare, review, and submit CTD / eCTD dossiers (Modules 1–5) - Regulatory Compliance:
Ensure alignment with ICH, USFDA, and EMA guidelines - Lifecycle Management:
Handle variations, renewals, and deficiency (query) responses - Technical Documentation Review:
Evaluate CMC documentation, stability data, and formulation development reports - Cross-Functional Coordination:
Act as a regulatory interface between R&D, QA, QC, and Manufacturing teams - eCTD Publishing Support:
PDF compilation, hyperlinking, bookmarking, and submission readiness
✅ Candidate Profile
- Qualification: B.Pharm / M.Pharm
(Formulation background is mandatory) 🎓 - Experience: 2–4 years in Regulatory Affairs (EU & US markets)
- Technical Expertise:
Strong understanding of CMC requirements, stability studies, and global regulatory expectations - Skills: Detail-oriented, compliance-focused, and confident in regulatory communication
📍 Location & Industry
- Location: Navi Mumbai, Maharashtra 🏙️
- Industry: Pharmaceuticals
📩 How to Apply
Interested candidates can share their updated CV:
- Contact Person: Shrutika
- Email: shrutika@mangrowhr.com
- Call / WhatsApp: +91 86557 35685
- Recruitment Partner: Mangrow HR Recruitment
