Ashok Reddy Yaram

WORK HISTORY

EDUCATION

ABOUT ASHOK REDDY YARAM

My self-summary: I completed my Masters of Pharmacy in Pharmaceutical Chemistry. I currently have 3 years of experience in the regulatory affairs field in pharmaceuticals. I am a very diligent, self-motivated, and detail-oriented person with excellent organization, communication, and computer skills. What I am currently doing: Working as Regulatory Affairs Executive at CIRO Pharma Pvt Ltd, I am currently handling regulatory activities related to the Domestic & Export market. I am involved in lision & dossier preparation, lifecycle management activities (submissions, safety communications, variation submissions, query responses, etc.), and related activities. I’m really good at: Ensuring regulatory compliance, devising regulatory strategies, and coordinating documents to support drug/biological/medical device marketing applications for India. I have knowledge of regulatory requirements for US and Asia. Willing to learn about other areas and roles of regulatory affairs professionals. • Well-versed with the concepts of (Drug/Medical Devices) Regulatory Affairs, like ICH Guidelines, CTD, eCTD, SmPC, PIL, Labelling, NDA, ANDA, SNDA, INDA, Para IV Application, First to file (FTF) of drug product, Post-approval activities, Dossier, Biowaiver, DMF, AMV, PDR, FDR, MedDRA coding, Argus database, QbD, ISO 13485, 14971, EU MDR 2017/745, 510(k), and 21 CFR 820, GMP, GLP, GDP, data integrity, and pharma compliance. An effective communicator with honed interpersonal, analytical problem-solving, and motivational skills. Superior computer operating and internet surfing skills, including experience in handling tools and software such as Microsoft Word, Excel, and PowerPoint