Ramana Kumar. K

About Ramana Kumar. K

Expert in authoring, reviewing CMC (Quality Modules 1, 2 & 3) part of the registration dossiers (NDA/ANDA/MAA/IMPD /IND/NDS/ANDS) in accordance with the country specific regulatory requirements & submitting periodic updates in paper and/ or eCTD format. Expertise in Filing DMFs for US, Europe, Canada, Japan, Korea, Taiwan, China, Brazil and Rest of the World Markets in paper and/ or eCTD format and writing, reviewing CMC sections. Expertise in US FDA Self Identification, Electronic drug listing and site establishment registration SPLs via FDA ES Gateway. Expertise in reviewing and submitting product variations to the approved MAAs in the EU through various submission procedures like DCP, MRP and National. Experience in authoring, reviewing the Type-II DMF, ASMFs (EDMF), CEPs and CEP variations (CMC sections). Expertise in defining CMC regulatory strategies for new products during development, global expansion and Cost Improvement Projects across all global markets for existing registrations. Expert in handling issues related to Genotoxicity during launches and can guide the product development teams during development to avoid Genotoxicity issues in the product life cycle. Expertise in starting material selection, justifying existing starting materials in view of complex requirements of EDQM, USFDA, Health Agencies in EU and Regulatory submissions with QbD. Experience in handling Regulatory submissions with COFEPRIS (Mexico Regulatory Agency). Expertise in handling deficiencies for APIs in worldwide markets with focus on Europe & USA. Proven experience in handling innovator clients in strategizing the Regulatory requirements / pathway to support their projects from Dr. Reddy´s Mexico site. Proven experience in streamlining of regulatory activities in view of compliance and implementation of regulatory guidances at Global Regulatory Affairs.

Experience

1. Director Regulatory Affairs Api

   Cipla

   Nov 2022 — Present · Mumbai, IN

Education

• Osmania University

  Msc, Organic Chemistry

  2005 — 2007

• Indian School of Business

  PGPPro-Master of Business Administration - MBA, Strategy and Leadership, Marketing

• Balayesu Vidyalaya

  Matriculation

  1985 — 2000

• A.P.R.J.C Nagarjuna Sagar

  10+2, MPC

  2000 — 2002

• INSEAD

  Global Strategic management and Corporate entrepreneurship

• Osmania University

  Bachelor's Degree, Maths, Physics, Chemistry

  2002 — 2005