Zarana Patel
About Zarana Patel
Zarana Patel is a Regulatory Affairs Executive with extensive experience in the pharmaceutical industry, currently working at Nivagen Pharmaceuticals, Inc. since 2019. She specializes in change control processes, document preparation, and regulatory submissions, particularly for the US market.
Work at Nivagen Pharmaceuticals
Zarana Patel has been serving as a Regulatory Affairs Executive at Nivagen Pharmaceuticals, Inc. since 2019. In this role, she is responsible for initiating change controls and assessing their impact on related documents and product quality. Her work involves the preparation and review of Standard Operating Procedures (SOPs), ensuring compliance with industry regulations. Patel's expertise includes preparing Module 3 of the electronic Common Technical Document (eCTD) for Abbreviated New Drug Application (ANDA) submissions in the US market.
Experience at Amneal Pharmaceuticals
Prior to her current position, Zarana Patel worked at Amneal Pharmaceuticals Pvt. Ltd. for a total of eight years, from 2011 to 2019. During her tenure, she held the position of Executive and contributed to various regulatory affairs initiatives. Patel's experience at Amneal Pharmaceuticals provided her with a solid foundation in regulatory compliance and documentation processes.
Education and Expertise
Zarana Patel possesses a strong understanding of regulatory bodies such as the FDA, WHO, and EMEA. She is well-versed in their guidelines for document preparation, which is crucial for ensuring compliance in the pharmaceutical industry. Her expertise extends to the preparation and review of batch manufacturing records for various dosage forms, including tablets, capsules, and granules for oral suspension.
Background
Zarana Patel has accumulated over 13 years of experience in the pharmaceutical industry, with a focus on regulatory affairs. She has worked in various capacities that have enhanced her knowledge and skills in regulatory compliance, documentation, and quality assurance. Her career has been primarily based in the United States, specifically in Bridgewater, New Jersey, and Sacramento, California.