This document contains a resume for Ajay Chandrakant Rekha Chavan. It summarizes his career objective to pursue a challenging career in drug regulatory affairs. It outlines his core skills in regulatory and documentation work. It also details his professional experience working as a regulatory affairs trainee officer at Medibios Laboratories from 2016 to present and as a quality assurance officer at Glow Pharmaceuticals from 2015 to 2016. It provides information on his education and interests.
1. Ajay Chandrakant Rekha Chavan
Room No.02 B/H P-9, Pragati residential Complex, Fatherwadi,Vasai (E) 401208.
Ph: +918600943241 Email: chavanajay93@gmail.com
CAREER OPBJECTIVE
To pursue a challenging career in Drug Regulatory affairs and become a part of esteemed organization where
I can use my skills, understanding and experience to bring out the best results and contribute to the growth of
the organization.
CORE SKILL SET
Functional:
• Regulatory.
• Documentation
PROFESSIONAL EXPERIENCE
Medibios Laboratories Pvt Ltd-Mumbai,India
Regulatory affairs trainee officer Feb 2016- Present
• Handling new drug product registration for African countries and North American countries
• Checking of BMR and BPR
• Checking of artwork for new product marketing
• Handling and checking Stability study report
• Prepared dossiers’ for Ghana, Nigeria, Zambia, Tanzia, Guiana, Chile, Paraguay.
• Application of Additional new product licence, COPP, and FDA related documents.
Glow Pharmaceuticals- Vasai, India
Quality Assurance Officer July 2015- Feb 2016
• Involvement and updating of Process Validation, Process Verification, Equipment Validation records.
• Assisting in preparation of document like SOP (Standard operating Procedures), for Production
(Tablets & Capsule Depts...).
• Assisting in preparation of formats to record various activities like in-process record, stereo control
record, Batch Register, Overprinting activity Record, Packing records etc.
• Successfully faced the Nigeria audit.
• Tablet, Capsule & Packing
Meyer Organics –Thane, India
Regulatory Officer (Internship) May- 2015 - June 2015
• Handling new drug product registration, subsequent new drug application, post approval variation and
regulatory activities and regulatory process and system development.
2. • Prepared dossiers’ for Ghana, Nigeria, Zambia, Tanzia, Guiana.
EDUCATION
BACHELOR OF PHARMA IN 2015.-Mumbai University, Graduate with first class
Diploma in Basic Computer Operating with A grade from soft tech education, Vasai
Achievements and Seminars attended
• Workshop on Pharma Journalism & Nutraceuticals organized by IPA-SF Workshop on
Pharmacovigilance & Nutraceuticals organized by IPA-SF
• Attend two day national conference on “TRANSLATIONAL RESEARCH IN ONCOLOGY FROM
BENCHSIDE TO BEDSIDE”
• Topper of the institute in 1st Year B.Pharmacy
Co-curricular Activities
• Volunteer in “PRE-DIABETIC CAMP” & “CARDIAC SCREENING CAMP “ conducted at AIKTC
School of Pharmacy in 2012-13 & 2013-14 Respectively
• Co-coordinator for FIRST-AID Team During Sports fest in the period of 1st
year to final year
B.pharmacy
INTERESTS
Passionate about Music, Cooking, Cycling, Playing Cricket, Teaching and Social
LANGUAGES
English (Fluent), Hindi (Fluent), Marathi (Mother Tongue)
PERSONAL DETAILS
Gender: Male
Date of Birth: 13th
August 1993
Marital Status: Unmarried
Contact Number: +918000943241