Swati Warudkar

About Swati Warudkar

Experienced scientist with 8 years of pharmaceutical and 4 years of research experience • Prepared and reviewed documentation related to global regulatory submissions and quality-related documents, wrote CMC sections of IND and NDA, advised on regulatory requirements related to product and API GMP manufacturing• Knowledge on the product development process and the product lifecycle for pharmaceutical and medical devices, including post-marketing commitments, post-approval manufacturing changes, post-approval submissions to the NDA/BLA• Good knowledge of requirements and approaches to create and maintain compliance with quality system, including strategies for minimizing and handling potential crises • U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. • Good understanding of planning process for Clinical Plan and regulatory submissions to the FDA, protocol development and implementation, including study site selection, financial controls, timelines, and management of the site\'s operations; proper informed consent; Good Clinical Practices compliance; HIPAA; FDA regulations and guidelines; and post-market support studies.• Well versed the basic elements of the clinical data management process. This includes good principles and practices applicable to the development and implementation of drugs and medical devices in a research environment. • Experience with, informed consent process, the make-up and function of Institutional Review Boards (IRB), the IRB review process, and basic biomedical ethics. • Expert user of electronic databases. Good knowledge about the handling, processing, storage, retrieval, and electronic submissions of clinical data.

Experience

1. Associate Director, Cmc & Supply Chain

   Tarsus Pharmaceuticals, Inc.

   Feb 2023 — Present

Education

• Nagpur University, India

  MS in Biochemistry, Clinical Biochemistry

  1985 — 1987

• UC Irvine

  Certificate in Regulatory Affairs and Compliance device track, Regulatory Affairs and Compliance

  2015 — 2016

• UC Irvine

  Certificate course, Clinical Trials: Medical Device and Drug Development

  2007 — 2008

• Nagpur University, India

  Bachelor of Science (BS), Microbiology and Chemistry

  1982 — 1985

Skills

• Analytical Chemistry
• Gel Electrophoresis
• Chemistry
• Biotechnology
• Protein Purification
• Life Sciences
• Gmp
• Pharmaceutical Industry
• Fda
• Chromatography
• Molecular Biology
• Qpcr
• Biochemistry
• Glp
• Clinical Trials
• Elisa