Are you an M.Pharm graduate with experience in CMC (Chemistry, Manufacturing, and Controls) for injectables? A leading pharmaceutical company is hiring a Regulatory Affairs Associate in Digha, India, to manage ANDA submissions, regulatory filings, and compliance for oral solids (tablets, capsules) and sterile liquid dosage forms.
This is a full-time opportunity with a fast-growing pharmaceutical firm, offering a chance to work on ANDA filings, supplements, and FDA correspondence.
Key Responsibilities
As a Regulatory Affairs Associate, you will:
✔ Prepare and submit ANDA filings in eCTD format for US FDA.
✔ Review CMC documents (Master Formula Card, PDR, BMR, BPR, Validation Reports).
✔ Compile controlled correspondences (Q1/Q2 queries, BE guidance, excipient queries).
✔ Assist in regulatory strategy development for product approvals.
✔ Conduct knowledge-sharing sessions on regulatory updates.
✔ Ensure compliance with FDA guidelines for oral solids and sterile injectables.
Eligibility Criteria
✅ Qualification: M.Pharm
✅ Experience: 1+ years in CMC for injectable formulations (preferred).
✅ Skills:
- Knowledge of ANDA submissions & eCTD format.
- Understanding of FDA regulatory guidelines.
- Strong documentation & analytical skills.
About the Company
A globally recognized pharmaceutical firm specializing in generic drug development, with a strong pipeline of oral solids and sterile injectables. The company is known for:
🔬 Cutting-edge R&D in formulation development.
🌎 Global regulatory compliance (US FDA, EMA).
📈 Career growth opportunities in regulatory affairs & CMC.
How to Apply?
📅 Last Date: April 30, 2025
