Prashant Dighe

Background

About Prashant Dighe

Presently working in Sun Pharma Ltd. I am a dedicated professional with about 18 years of experience in Regulatory Affairs, specialized in Injectables (Peptides, devices, combination products)and Solid oral dosage forms. My job responsibilities are: US Market: • Key role includes preparation of regulatory strategy notes, providing regulatory pathways, submission management and strategic input during developmental projects (Specification finalization, stability design, Q1/Q2 assessment, IIG, HF study requirement evaluation etc). • Planning and submission of NDA/ANDA for US market and post approval activities. • Management of Deficiency (CRL, IR, DRL) responses to pending NDA/ANDAs, supplements. • Evaluation and submission of Pre-IND/NDA meeting request and briefing package and arranging meeting with FDA. • Technical writing, review and timely submission of supplements (CBE-0, CBE-30, PAS and Annual reports). • Controlled correspondence submission to seek FDA’s advice on technical/regulatory requirements. US and CA Labeling: • Review and submission of labeling, SPL • IR/DRL/ CR/ Clarifax response - Support in launch of new products EU and CA Market: • Key role includes preparation of regulatory strategy notes. • Planning and submission of MAA (Hybrid and generic) and ANDS application and query responses. • Technical writing, review and timely submission of Variations (Type IA, Type IB and Type II). • Scientific advice submission to seek Agency’s advice on technical/regulatory requirements. New product Evaluation for US and OAM (EU, CA, AU and NZ) market: • Evaluation of possibility of extension of dossier from one market to another market. • Evaluation of additional requirements and documents. • Drug Master File (DMF) evaluation and coordination with vendor to resolve queries. • Being Project co-ordinator involved in setting projects timeline, coordination with various departments, monitoring ANDA activities, project status updation, arranging meetings with internal departments to resolve issues and to ensure timely completion of task set forth in timeline. • Training to various manufacturing sites on newly published FDA guidance’s and updated regulatory requirements. • Designing and creating various databases using proficiency in MS-Excel in order to track and retrieve regulatory information determining approval time.