Kshitij Thakkar

About Kshitij Thakkar

Responsible for the development, maintenance, and implementation of Company Core Data Sheets (CCDS) in line with international standards and guidelines.• Provide strategic and tactical labeling expertise and labeling operational leadership to cross functional teams for successful development of regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC], target product labels and core data sheet (CDS) documents to teams.• Subject Matter Labeling expert for the implementation of end-to-end Labeling system and process for a major Pharmaceutical company to address CAPA and audit inspections.• Reviewed/authored aggregate reports (PSURs, ASRs) and on specific safety issues) and performed cumulative safety reviews in preparation of responses to adhoc queries from regulatory agencies world-wide. Have an understanding of epidemiology relevant to Phamacovigilance (using comparative safety data and epidemiological study analyses). Have gained expertise in CIOMS and ICH guidelines, GCP guidelines, reporting rules. Participated in DIA sponsored annual conferences, tutorials and webinars to gain an in-depth cross-functional understanding of industry and regulatory agency. As an author for several aggregate reports, have a MedDRA best coding practices knowledge and its utilization towards writing aggregate reports. Have a working knowledge of ARGUS 7.• Experienced in documentation design, development and control with excellent usage of document repositories and workflow such as Microsoft Enterprise Collaboration Framework (ECF): ISIToolBox, ISIWriter, eDMS, share point and Live Link. Authored cGMP technical reports which included critical and risk analysis reports, flow diagrams and stability protocols. Technical support of external Manufacturing and packaging.• Record of delivering multiple promising small-molecule therapeutic agents (6 candidates) which demonstrate efficacy and acceptable safety in human clinical trials in metabolic disorders/oncology/immunology therapeutic areas. • A track record of 22 patents and patent applications, 22 publications and presentations. • Expert in applying modern medicinal chemistry principles to the identification, optimization, and development of small-molecule therapeutic agents. • Extensive teamwork, coordination, and management experience. Ability to co-ordinate external contractors. Extensive experience with the synthesis and scale-up of small-molecule drug candidates.

Experience

1. Director, Regulatory Labeling

   Madrigal Pharmaceuticals

   Jan 2025 — Present

Education

• Rensselaer Polytechnic Institute

  NIH Post Doctorate

• L. M. College of Pharmacy

  B. Pharm, Pharmacy

• Purdue University

  Ph.D. in Medicinal Chemistry and Pharmacology working on tyrosine kinase inhibitors

• Rutgers Business School

  Process Improvement: Lean six sigma Certification, Business Administration and Management, General

• Rutgers Business School

  Professional Certificate, School of Business- Executive Education