Inari

Dr. Anand Babu Vangala

About

Dr. Anand Babu Vangala
Director Centre of Regulatory Affairs

Dr. Anand Babu Vangala is a seasoned expert in regulatory affairs and clinical research, with extensive experience of 8 years in managing the regulatory landscape for in vitro diagnostic (IVD) devices. As the current Head of Regulatory Affairs at Neuome Technologies Pvt Ltd., Bangalore, since December 2021, Dr. Vangala has led numerous successful regulatory submissions, including ISO 13485 certifications, FDA, and CDSCO applications. His expertise in Quality Management Systems (QMS) and TUV audits has been crucial in maintaining compliance with global standards. Dr. Vangala’s role involves the meticulous preparation and submission of regulatory documents, managing communication with regulatory bodies, and ensuring that all products adhere to the necessary regulations. His deep understanding of regulatory requirements and proficiency in handling complex regulatory processes has significantly contributed to the company’s growth and compliance. Prior to his current position, Dr. Vangala served as a Regulatory Affairs Associate at Berlin Heart GmbH, where he was instrumental in the regulatory aspects of medical devices. His responsibilities included preparing regulatory submissions, coordinating with regulatory authorities, and ensuring that all products met stringent regulatory standards. In addition to his regulatory expertise, Dr. Vangala has significant experience in clinical research. As a Clinical Research Associate at the mibeg Institute of Medicine in Cologne, he was responsible for planning and conducting clinical trials, writing clinical trial protocols, obtaining ethics committee approvals, and preparing essential study documents such as Informed Consent Forms (ICF) and Case Report Forms (CRF). His thorough knowledge of ICH-GCP guidelines and clinical trial management has been pivotal in the successful execution of clinical studies. Dr. Vangala holds a Ph.D. from Heinrich Heine University, Düsseldorf, where his research focused on the role of the Vip1 kinase family member Asp1 in the morphogenesis of the fission yeast Schizosaccharomyces pombe. He also earned a Master’s degree in microbiology from Friedrich Schiller University, Jena, with his thesis research conducted at the Karlsruhe Institute of Technology, investigating antibiotic resistance in Pseudomonas aeruginosa. His dedication to professional development is reflected in his certifications in Good Manufacturing Practice, clinical research skills, and project management. Dr. Vangala’s technical expertise spans molecular biology techniques, protein methods, gene expression analysis, and the design and evaluation of experiments. An active contributor to the scientific community, Dr. Vangala has presented at numerous conferences and published several papers. His extensive experience in regulatory affairs, clinical research, and compliance with international standards makes him an outstanding candidate for a faculty head position, where he aims to continue advancing the field of clinical research and regulatory science.