SG

Sucheta Goyal

Regulatory Affairs Manager at maruho medical

Sucheta Goyal has extensive work experience in the field of Regulatory Affairs and Quality Assurance. Sucheta is currently working as a Regulatory Affairs Manager at Maruho Medical, a position they started in August 2022. Prior to this, Sucheta worked at BD as a Regulatory Affairs Specialist from July 2020 to August 2022.

Before joining BD, Sucheta worked at Zimmer Biomet as a Regulatory Affairs Specialist for four years, from October 2016 to July 2020. In this role, they were responsible for designing and developing Quality Management Systems (QMS) and Regulatory Compliance Programs for medical devices, ensuring compliance with ISO 13485:2016, MDR, FDA 510(k), and CE Marking requirements.

Sucheta also gained valuable experience at Amneal Pharmaceuticals, where they held multiple roles from 2012 to 2016. Sucheta started as a QA/RA and was involved in preparing Standard Operating Procedures (SOP) and analytical documents. Subsequently, they worked as a Scientist II & Technical Writer and later as a Scientist I, contributing to method validation, stability reports, and batch analysis.

In addition, Sucheta has worked at Belcher Pharmaceuticals as a Quality Assurance Specialist and Quality Assurance Associate, playing a key role in formulating pharmaceutical products, conducting experiments, and ensuring compliance with guidelines.

Earlier in their career, Sucheta worked as a Graduate Teaching Assistant at the New Jersey Institute of Technology, where they taught engineering models in physiology and solved mathematical models using Matlab. Sucheta also worked as a Research Assistant at Ranbaxy, contributing to the development of a new antibiotic.

Sucheta started their career as an intern at Siemens, where they gained hands-on experience in agarose gel electrophoresis, SDS-PAGE techniques for DNA purification, and plasmid DNA isolation.

Overall, Sucheta Goyal's work experience demonstrates their expertise in regulatory affairs, quality assurance, and research, making their a highly qualified professional in the field.

Sucheta Goyal completed their Bachelor of Science (BS) degree in Biotechnology at the University of Rajasthan, from 2003 to 2007. Sucheta then pursued a Master's degree (MS) in Bioengineering and Biomedical Engineering at the New Jersey Institute of Technology from 2009 to 2011.

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Timeline

  • Regulatory Affairs Manager

    September, 2022 - present