Raghu Rama Setty A. M.Pharm, PDMW has extensive work experience in the field of medical and regulatory writing. RAGHU RAMA is currently working as an Associate Vice President and Head of Regulatory Medical Writing at SIRO Clinpharm Pvt. Ltd. In this role, they supervise and drafts various documents such as clinical overviews, clinical summaries, non-clinical overviews, and clinical study reports. RAGHU RAMA is also responsible for the development of briefing packages, feasibility reports, and submission processes for IND, NDA, BLA, MAA, and other applications.
Prior to their current role, Raghu Rama Setty has worked at Freyr Solutions as a General Manager and Head of Medical Writing. RAGHU RAMA has also held roles as Deputy General Manager, Assistant General Manager, Senior Manager, and Manager at Freyr Solutions. In these positions, they have overseen the drafting of common technical documents and development of clinical, nonclinical, and toxicological documents.
RAGHU RAMA has also worked at Hospira Healthcare India Private Limited as a Deputy Manager and Assistant Manager in the Medical and Regulatory Writing departments. In these roles, they were involved in research, writing, and editing of regulatory-related documents and was responsible for drafting study protocols, investigator brochures, and clinical trial summaries.
Furthermore, Raghu Rama Setty has worked at Bioplus Lifesciences as a Senior Executive in the Clinical and Regulatory Affairs Department. RAGHU RAMA was responsible for preparing dossiers for submission in regulated and emerging markets and preparation of product characteristics and patient information leaflets.
Earlier in their career, they worked at UBM India Pvt Ltd as a Content Specialist in Clinical and Medical Writing, providing medical support to pharmaceutical companies and preparing customized monographs. RAGHU RAMA also worked at Micro Labs Ltd. as an Executive in Clinical Research, where they audited CROs, reviewed bioequivalence study protocols, and wrote expert reports.
Raghu Rama Setty started their career as a Lecturer at Anupama College of Pharmacy, where they taught biochemistry, pharmacology, anatomy and physiology, and hospital and clinical pharmacy.
Overall, Raghu Rama Setty has a diverse range of experience in medical and regulatory writing, demonstrating expertise in drafting various documents, overseeing teams, and coordinating submission processes for regulatory applications.
Raghu Rama Setty A. has an extensive education history in the field of pharmacy and pharmaceutical sciences. They obtained a Doctor of Philosophy (PhD) degree in Pharmaceutical Sciences (Pharmacology) from Amity University, Greater Noida Campus, starting in 2021 and completing in 2025.
Prior to their PhD, Raghu Rama Setty A. earned a Professional Diploma in Medical Writing (PDMW) from James Lind Institute in 2014. They also completed a Professional Course in NMR Spectroscopy: Applications to Biological Systems at the Indian Institute of Science (IISc) in 2007.
In 2007, Raghu Rama Setty A. obtained a Master of Pharmacy (M.Pharma) degree in Pharmacology from the Government College of Pharmacy in Bangalore, Karnataka. Prior to that, they completed a Bachelor of Pharmacy (B.Pharma) degree from the same institution in 2003.
Their educational journey started with a Diploma in Pharmacy (D. Pharma) from TVM College of Pharmacy in Bellary, Karnataka from 1997 to 1999. They also pursued PUC (Pre-University Course) in Science PCMB from Sri Kottureshwara College from 1993 to 1995.
In addition to their academic qualifications, Raghu Rama Setty A. has also obtained additional certifications. They are a certified Lean Six Sigma Green Belt from Anexas Denmark, UK, which they obtained in 2015. They have also completed an Advance Excel certification from Coalesce Technologies Pvt. Ltd. in 2014.
September, 2022 - present