- Reviewed DMFs and communicated with their vendors for smooth US FDA regulatory submissions including ANDAs, NDAs to achieve first cycle approval. - Responsible to escalate issues and inform project status to higher management for all drug substances related activities starting from choosing vendor to deficiency resolution and post approval changes.- Assessed administrative as well as CMC analytical regulatory documents up to date for all the major formulation like solid orals, parenteral, transdermal, topical, complex, drug device combination etc.- Achieved timely submission of deficiency responses (IR, CRL, Filing Review comments), amendments, through organizing, presenting & concluding effective meetings with CFTs like analytical development, supply chain, drug substance supplier, business development, QA, QC, R&D. - Maintaining tracker & archiving responses. Reduced approval time by taking advantage of GDUFA III, tracking of DMF changes, evaluating the impact of proposed changes and proactive communication with vendors/ CDMO/ CRO. - Part of core regulatory team responsible for project leadership and management deliverables. - Streamlined tracking of DMF change notifications and evaluating the impact of proposed changes.- Assessed, change controls through change control management system to comply with current regulatory requirements by coordination with internal and external stake holders. - Executed regulatory intelligence strategy to accomplish difficult approval through communication with FDA and actively involving in regulatory strategies and compliance with internal and external stakeholders. - Effective use of resources like meetings and controlled correspondence to communicate to the regulatory agencies.

- Conceptualized all Nitrosamine risk assessment related activities as per changing requirements from health authorities and provided effective regulatory support. - Prepared artwork, Structured Product Labeling, side by side label, proof review, Drug listing on daily med, by working effectively with FDA, packaging team, artwork suppliers, assuring brand design guidelines. - Responsible for REMS communication submissions, promotional labelling - Working effectively with commercial/supply chain team to give exact information on regulatory front like PLAIR approval, last minute RLD label changes for effective launch planning, risk mitigation & commercial readiness.- Responsible for assigning NDCs and maintaining NDC database. Managing all FEI, DUNS related activities.- Motivated & trained subordinates with effective work delegation to review & prepare regulatory documents.

- Contributed for lifecycle management (PAS, CBE30, CBE0 and annual reports) and Module 1 preparation. - Prepared and assisted different regulatory submissions in like CP, DCP, MRP, NP and variations for Europe filing. - Assisted in different CMC document review and regulatory module preparation.

- Specialized in analytical method development, validation, stability studies, cleaning validation for different pharmaceutical formulations with various instruments like UV, HPLC, GC, MS, NMR, AAS, XRD and data interpretation. Managed successful method transfer to different laboratories. - Performed analytical development of different formulation like Parenteral, solid orals, transdermal, etc.- Well-versed with different analytical instruments and their software.