Vijayakumar Balasubramanian

About Vijayakumar Balasubramanian

A Pharmaceutical professional offering to proven skill-sets in driving various…

Experience

1. Head - Regulatory Affairs

   Harman Finochem Ltd

   Feb 2014 — Present · Aurangabad, IN

   Spearheading a skilled team of 15 members in Regulatory Affairs Department.Reviewing and submitting DMF/E-DMF/CEP to US-FDA, Europe, EDQM, Health Canada, PMDA, China, Russia, Korea, Brazil and Rest of World. Preparing the DMF, CEP & ASMF submission plan and daily departmental activities. Providing quality response to the Regulatory agencies queries, Customer queries and Regulatory audit inspection report.Imparting training for DMF compilation, submission, guideline to build regulatory team of well-rounded professionals.Evaluating new generic APIs for its suitability of manufacturing in the regulatory plant with respect to regulatory requirements and GMP practices and guiding the management.Monitoring and communicating new and changing regulation / updating with legislation changes and anticipating their impact on the current and proposed approvals.Assessing and approving the change controls, deviations, vendor qualification and process validation documents.Maintaining the life cycle of submitted DMF/CEP/ASMF; submitting the annual reports, amendments (CBE 30 and PAS) and variation filings as per the stipulated timeline.Drove the implementation of the eCTD software and converted the US DMF, Health Canada DMF, CEP Dossiers and European ASMF’s (DCP and National) to eCTD from paper format.Providing leadership and supporting interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks like regulatory pre-market approval and international registration deliverables) submissions.Analyzing department budget status on revenue and capital expenses with the Finance Department on periodic basis.Maintaining current knowledge of FDA, Health Canada, EMA, and ICH requirements for regulatory submissions and ensuring that all regulatory submissions comply with those requirements.Excels in contributing and participating in the review of process/product changes, complaints.

Education

• Bharathidasan University, Tiruchirappalli

  Doctor of Philosophy - PhD

  2015 — 2020

• Annamalai University

  M.Sc

  1998 — 2000

• Thiru. Vi. Ka. Government Arts College, Thiruvarur - 610 003.

  Bachelor of Science - BS

  1993 — 1996

Skills

• Capa
• Regulatory Requirements
• Gmp
• Gxp
• Quality System
• 21 Cfr Part 11
• Glp
• Pharmaceutics
• Generic Programming
• Validation
• Quality Assurance
• Clinical Trials
• Organic Chemistry
• Pharmaceutical Industry
• Sop
• Hplc
• Ectd
• Anda
• Regulatory Submissions
• Change Control
• Analytical Chemistry
• Regulatory Affairs