CMC Regulatory Writers

Job Description

CMC Regulatory Writers, we’re looking for you! In #Celegence,we’re hiring an experienced Senior CMC Regulatory Writer with 6+ years of experience to join our team in Jayanagar, Bengaluru. 📍 Location: Jayanagar, Bengaluru 🏢 Mode: Hybrid 💼 Experience: 6+ years What we’re looking for: ✅ Strong expertise in CMC Module 2 & Module 3 writing ✅ Experience with IND/IMPD and BLA/MAA submissions ✅ Ability to analyze PDR, BMR, MFR, Stability Data and other CMC source documents ✅ Experience handling Health Authority Queries (HAQs) ✅ Strong understanding of ICH guidelines and global CMC regulatory requirements ✅ Ability to independently author, review and deliver submission-ready documents ✅ Excellent scientific review, QC, stakeholder management and project coordination skills ⭐ Experience with Biopharmaceuticals and/or Gene Therapy submissions is highly preferred. If you have been working on complex CMC submissions and are ready for your next opportunity, we’d love to connect with you! 📩 Interested candidates can apply through LinkedIn or share their updated CV at careers@celegence.com. Know someone suitable? Tag them in the comments or share this post with your network!