Ritesh W Lohe

About Ritesh W Lohe

Regulatory Affairs professional with Master’s degree in Pharmaceutical Science (M. Pharm) and 11.8 years (total 13.8 years) of experience in reputed pharmaceutical companies, predominantly for formulation registration in US market.

Experience

1. Senior Manager

   Alembic Pharmaceuticals Limited

   Nov 2017 — Present · Hyderabad, IN

   Global Markets Regulatory Affairs Experience: A. US Market: • Regulatory support for Product Portfolio Selection, • Pre-ANDA Product Development Meetings, Scientific Package Writing, Controlled Correspondence, • Competitive Generic Therapy (CGT) applications, • Summary Basis of Approval (SBOA) of RLD, • Pre-Submission Facility Correspondence (PFC), • Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs, 505 (b)(2)), • Commercial Launch Activity, Approved Product life cycle management, • Field Alert Report (FAR) & Pre-Launch Activities Importation Requests (PLAIR), Safety Adverse events (AEs) reporting. B. Europe Market: • Regulatory support for Product Portfolio Selection, Scientific Meetings with the Agencies, • Decentralized Procedures, • Regulatory Affairs support across the lifecycle (variations and renewals). • Customer handling for dossier due diligence, • Respond to queries received from Regulatory authorities & customers. C. Canada: • Scientific Meeting with Agencies, ANDAS compilation monitoring, Correspondence with Health Canada, Customer handling for dossier due diligence, respond to queries received from Regulatory Authorities & customers.

Education

• Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur

  Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences

  2000 — 2004