Ch V V Pavan Kumar

About Ch V V Pavan Kumar

Result-oriented professional with 20 years of progressive experience in global pharmaceutical regulatory affairs for regulated market. Drug product life cycle management for US/EU/AUS/CND marketed products. To formulate regulatory strategy and tactics for all appropriate regulatory submissions (ANDA, ANDS, MAA, SANDS, PAS, CBE, Type I & II variations and CAT and ensure timely approval of the submissions from the regulatory authority. Proven management skills in leading Corporate Strategic Plan Initiatives, mentoring junior Associates to be proficient in regulatory submissions. Thorough and extensive knowledge of drug development process, manufacturing, product launch activities and change control process. Providing regulatory inputs and on job training to the team members for post-approval changes on regular and need basis and based on the common deficiencies received. Building and implementing the Regulatory strategies, expertise and involvement in managerial decisions. Approaching with health agencies for perusing the required information for submissions. Updated with latest developments with respect to submission like eCTD and CTD formats, SPL labeling. Excellent inter personal and project management skills and ability to manage multiple projects simultaneously based on priority. Good understanding of various regulatory requirements and ICH Guidelines.

Experience

1. Agm Regulatory Affairs

   Hetero

   Jan 2024 — Present

Education

• Board of Health Sciences, Bangalore

  D.Pharmacy

  1995 — 1997

• Rajiv Gandhi University of Health Sciences

  B.Pharmacy, Pharmaceutical

  1999 — 2003

• Annamalai University

  M.Pharmacy, Industrial Pharmacy

  2005 — 2007

Skills

• Pharmaceutics
• Ectd
• Anda
• Technology Transfer
• Pharmacovigilance
• Gmp
• Generic Programming
• Glp
• Regulatory Affairs
• Plcm
• Ands
• Regulatory Submissions
• Gcp
• Formulation
• Cmc
• Maa
• Pharmaceutical Industry
• Sop
• Fda
• Change Control
• Regulatory Requirements