• A PMP® certified Project Management Professional, Patent Agent and Registered Pharmacist based in India, having M. Pharm. in Pharm. Chemistry. • 14+ years of experience in cGMP compliant Technical Research & Development supporting Analytical operations, Quality assurance, Quality control, Project management in coordination with Regulatory affairs (Reg CMC) to secure fast high-quality marketing authorization approval. • Executed experiments to deliver analytical method development, validation, stability studies and authored technical source documents for Development/Quality Module belongs to therapy area Cardiovascular (Entresto®), oncology (Kisqali® & Piqray®) and achieved successful IND/NDA/MAA submission by Regulatory affairs for marketing authorizations in US, EU & RoW. • I excel in coordinating with international cross-functional technical research teams and managing stakeholders in geographically dispersed environment with strong interpersonal and communication skills.