Regulatory Affairs Consultant I

Syner-G BioPharma Group is looking for a Regulatory Affairs Consultant to support a pharmaceutical client in Chemistry, Manufacturing, and Controls (CMC), with a focus on post-approval regulatory submissions. The role, based remotely in Bangalore, Chennai, Hyderabad, or Mumbai, involves providing strategic regulatory guidance and operational support to ensure compliance with FDA, EMA, and global regulatory requirements. The ideal candidate will bring scientific acumen, regulatory expertise, and leadership capabilities. Key responsibilities include leading and managing regulatory milestones, contributing to strategic regulatory discussions, developing and executing CMC regulatory strategies, authoring and reviewing global CMC submissions, collaborating with internal teams and external partners, and managing regulatory operational activities.