Regulatory Affairs Specialist

KEDAR PAI

*** ***** ***** ***, *** ***, Alameda, CA-94501 213–479-4277 acr9hd@r.postjobfree.com

PROFESSIONAL SUMMARY

An highly motivated, goal-driven, adaptable and enthusiastic regulatory affairs professional with an academic background in pharmacy and regulatory affairs of pharmaceuticals, biologics and medical devices, seeking opportunities in a fast-paced and deadline-oriented environment, looking to develop leadership responsibilities and organizational ability. PROFESSIONAL EXPERIENCE

Regulatory Affairs Specialist- Penumbra, Inc., USA Oct 2014-Present

• Prepared and revised Technical Files and International Dossiers for peripheral thrombectomy and neurovascular access devices

• Project lead for regulatory submission for registration and renewal of products in Asian, South American and European countries

• Project lead for Class III medical device submission, substantial change submission and 3 year renewal submission for EU countries

• Designed Clinical Evaluation Reports for NSAI, CFDA (China); assisted in preparing post market surveillance report for products

• Determined a Letter to file for shelf life extension of product worldwide, implemented actions as needed by respective country

• Successfully interpreted FDA guidelines to decide if modifications to device needed a new 510(k) submission or a Letter to File Regulatory Affairs Professional- Medivators, Inc., USA June 2014- Sep 2014

• Authored Engineering Change Orders for labels of products sold in Asian countries and EU by Medivators and sister companies

• Assisted in Regulatory filings for products in Brazil and other South American countries, filed FOI requests for 510(k)s

• Coordinated with Regulatory departments of various country offices, filed a Canadian fax-back amendment, ordered CFGs Regulatory Affairs Intern- Applied Biomedical LLC, USA Jan 2014- June 2014

• Determined regulatory pathway for device, organized meetings and worked closely with R&D to update product specifications

• Assisted and prepared Risk Management plan for the device, prepared cleaning validation protocol and usability engineering

• Interpreted FDA guidance and prepared premarket notification submission for a Class II glucose monitoring system for the US Student Intern – Consulting Center, International Center of Regulatory Science, USA Jan 2014- June 2014

• Project Head, prepared a case study on a client’s Clinical study hold due to FDA warning letter, and assisted in IND amendment

• Prepared a detailed report on Orphan Drugs, highlighting regulatory strategies and pathways used in the industry for approval R & D Intern- Wyeth India, Goa, India June 2011- July 2011

• Carried out content uniformity tests in accordance to USP for tablets, observed R&D transition from wet to dry granulation

• Monitored various storage, manufacturing and quality control activities in sterile, GMP facility for oral contraceptive tablets

• Prepared, executed shop floor order for manufacturing, assisted in preparation of batch manufacturing and packaging records Quality Intern- Abbott India, Goa, India Dec 2010-Jan 2011

• Monitored various manufacturing and quality control activities in non-sterile liquid formulation and tableting unit for antacids

• Documented and assisted in chemical assays of raw material and finished product using GCMS and neutralization titration tablets

• Examined and observed validation and verification of quality control tests, raw material and finished product assays RESEARCH PROJECTS

Pre-market Notification- 510k Submission Packet, University of Southern California Fall 2012

• Determined predicate device for class II implantable clip for ligation of blood vessels during endoscopic procedures

• Strategized Design Verification, biocompatibility and packaging testing of clip in compliance with ASTM and ISO standards

• Drafted the labelling and IFU for implantable clip in accordance to USFDA and proposed regulatory pathway required Determination of regulatory pathway for device in Japan and Korea Spring 2014

• Determined the class for synthetic heart valve to be marketed according to Korean and Japanese regulatory bodies

• Strategized the regulatory pathway to be followed for quick approval of the device in the Korean and Japanese medical market

• Compared the regulatory pathways for a class IV device in the two countries, time to approval of device, reimbursement Clinical Trial Protocol-Phase IV, University of Southern California Fall 2013

• Prepared an FDA submission-ready Phase IV protocol of Gabapentin as a prophylactic agent for migraines with/without aura

• Assisted in determination of primary and secondary outcomes for the study, designed/developed Informed Consent Forms

• Determined Power analysis and Sample Size for a multi-center clinical trial based on primary and secondary endpoints of study Project Head- Marketing Strategy for a GLP-1 Agonist (EU), USC Spring 2014

• Determined Regulatory pathway required for the novel drug to be marketed in the EU and EEA region.

• Assisted in developing a pharmacovigilance system required in the EU for investigational medicinal product

• Conducted research on the health and reimbursement policies and the impact of health technology assessment of drug EDUCATION

Masters in Regulatory Sciences, University of Southern California Aug 2012 - May 2014 Coursework: Quality Systems and Standards, Regulation of Drugs, Biologics and Medical Devices, Design and Management of Clinical Trials, Chemistry Manufacturing and Controls, Medical Product Law, Safety evaluation during drug development Bachelors in Pharmacy, Manipal College of Pharmaceutical Sciences July 2008 - May 2012 Coursework: Biomedical and Pharmaceutical Analysis, Industrial Pharmacy, Pharmaceutical Technology, Pharmaceutics, Pharmaceutical Biotechnology, Pharmaceutical Jurisprudence, Pharmaceutics, Pharmaceutical management PUBLICATIONS

• Pharmaceutical Marketing on the Internet – AN Nagappa & Kedar Pai Feb 2012

• E-prescribing: The future trends – AN Nagappa & Kedar Pai Aug 2012 AFFILIATIONS, SKILLS AND INTERESTS

• Member of

o RAPS

o ISPOR

• Volunteer at the Indian Pharmaceutical Congress (IPC), Manipal, India in 2010

• Head of Meeting and Planning Committee of KSPOR 11-12 (Student Chapter of ISPOR)

• Attended conference on UDI and Traceability of medical devices, volunteered at the MD&M Conference 2013, Anaheim

• RAPS Coursework – Pharmacovigilance

• Knowledge of HTML, JAVA and JavaScript

• Soccer captain for college at several state competitions, Taekwondo black belt, three time runner up-state level

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