TEJOBALA YARLAGADDA

** ***** ***** **, ******, MA - 02125 +1-617-***-**** adlf6e@r.postjobfree.com EXPERIENCE

Regulatory affairs Specialist, Suven Pharma, India Jun 2018-Dec 2018

• Contributed in preparation and review of SOP.

• Performed review on the advertising materials and provided input on regulatory compliance.

• Worked for the submissions of 510K, PMA and also provided regulatory input for lifecycle planning.

• Quality review of cases with CAPA and Deviation recommendations.

• Assisted product post market approval requirements and also evaluated preclinical, clinical and manufacturing changes for regulatory filing.

• Prepared and reviewed the regulatory submissions. Experiential Project Associate, Health Connexions May 2017- July2017

• Researched and reported regulations around CBD/THC related projects in India and the USA and recommended changes in government policies, laws or regulations to establish world leadership in the cannabis industry.

• Drafted an in-depth conference agenda as a platform for renowned speakers from the cannabis industry to share their experience and knowledge on cannabis leadership.

• Networked with professionals to learn about existing projects circling around medicinal and recreational cannabis use and researched areas where academic communities and other industries and businesses could bring their expertise to support world leadership.

Hospital Pharmacy Intern, NRI Super Specialty Hospital April 2017 - Apr2017

• Liaised with senior pharmacists for dispensing medicinal products and supplies required in wards, while ensuring safe and secure storage of all medicines and hospital supplies.

• Managed inventory using ABC and FSN analysis techniques and assisted with stock keeping of supplies.

• Developed knowledge about medication guides, therapeutic regimens, pharmaceutical package inserts and other labelling materials

Quality Assurance Intern, Divi’s Laboratories PVT. LTD May 2016- July 2016

• Performed quality control tests on numerous pharmaceuticals in accordance with Good Laboratory Practice (GLP) requirements; documented and compiled the test results for the same.

• Received training in test result documentation and SOP development for testing procedures and equipment handling and handled complex quality control testing equipment like HPLC, GC, FTIR. And LC/MS. PROJECTS

• eCTD Template - Created a template for the electronic dossier submission of INDs and NDAs.

• Marketing strategy development - Prepared a presentation describing regulatory strategy for oxycodone hydrochloride and acetaminophen tablets

• Regulatory pathway presentation - Drafted the pathway strategy for a device called Hemoblast bellows including classification, pathway to FDA guidance and applicable timelines.

• Regulatory History of Euflexxa – A summary of regulatory history of a device including details on the purpose of this device, device classification, duration since the device has been on the market and safety concerns of the device.

• Adverse drug reaction reporting - Filed an adverse drug reaction reporting form in compliance with Australia’s TGA standards. EDUCATION

Master of Science, Regulatory Affairs of Drugs, Biologics and Medical devices Sep 2019 – May 2021 Massachusetts college of Pharmacy and Health sciences Bachelor of Pharmacy Oct 2014 - May 2018

Acharya Nagarjuna University

SKILLS

Technical Skills: Microsoft Office and Access, Adobe Acrobat Regulatory Skills: Familiarity with FDA and ICH guidelines, CFR Title 21 Regulations, Submission dossier preparation, Regulatory strategy development, Regulatory Compliance

Contact this candidate