Mukesh Kumar is seeking a challenging career in drug regulatory affairs. He has over 2 years of experience working in regulatory affairs and medical writing at Regulatory Wisdom. His responsibilities included preparing regulatory strategies, dossier submissions, and labeling for food products. Previously, he worked 9 months in R&D at SC Johnson India. Mukesh holds an M.Pharm in Pharmacology and has experience conducting research projects screening plants for medical properties. He is a strong communicator with good interpersonal skills who enjoys learning new things.
1. MUKESH KUMAR
M.Pharm (Pharmacology)
B-86, Rama Park, NewDelhi
Mobile:+91- 8860316518
E-mail:kumarpharma1@gmail.com
Objective
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.
Experience and Work History
Experience-2yearplus(Total26months)(May2014- tilldate)
Organization-RegulatoryWisdom
Designation-AssociateRegulatoryAffairs
Job Profile
o Preparing and reviewing and implementation of Regulatory strategy in support of dossier
submission in compliance to CTD, ACTD format for different regulated and semi-
regulated markets.
o Involve in various activities to CDSCO including Import of drugs, filing of clinical trials
application (form 44), test license (form 11), and RC application (form 40) etc.
o Medical writing as per CTD guidelines and Preparation of PSUR
o Preparation of Dossier or Application as per FSSAI Rules & Regulations and their online
filling.
o Labeling of Food Products as per FSSAI Rules and Regulation.
Previous Organization: (From September 2013- May 2014)
9 Month experience in R&D department of SC Johnson India
Educational Qualifications
M.Pharm(Pharmacology)fromNIET,GreaterNoida(U.P.)with74.24% marksin2012.
B.PharmafromGRD(PG)IMT,Dehradun(U.K)with67.67% marks.
IntermediatefromKMVinterCollege,AtrauliAligarh(U.P.)with54.67% marks.
10thstandardfromKMV InterCollegeAtrauliAligarh(U.P.)with53.67% marks.
Project & Training
M. Pharm: Screening of the leaves of Cucurbita maxima for its antidiabetic, antioxidant
and antimicrobial potential.
Guide: Dr. Dr. Avijit Mazumder, Professor & Director, Deptt of Pharmacy, NIET.
B.Pharm Project on the topic-“ Formulation And Evaluation Of Floating Controlled
Microsphere Prepared By Solvent Evaporation Method
One month industrial training from Glenmak Pharmaceuticals Baddi, Solan. In Tablet,
Capsule and Parenterals.
2. Achievements &ExtraCurricular Activities
Diuretic activity of C. maxima, Presented in IPGA, Mathura, 2012
“A Polymer curse or boon to future” Presented in the International Symposium
on “Recent Advances in Green Chemistry” held at Manav Rachna International
University, Faridabad 2012.
Anti-inflammatory activity of Curculigo orchioids, Presented at 61st IPC
Ahmadabad, 2009.
Actively participated in various cultural fests and organized many events for the
Pharmacy week celebration.
Key Strength
Fast adaptability to new challenges and responsibilities.
Strong interpersonal skills and self confidence.
Working smartly, flexible and strong willingness to learn new things.
Goal and TeamOriented and can easily gel up with surrounding.
Leisure Interest
Playing Cricket.
Badminton.
Music
Personal Profile
Father’s Name: Mr. M. P. Singh
Mother’s Name: Mrs. Bhudevi
Date of Birth: 2nd March 1986
Languages known: English, Hindi
Declaration
I hereby confirm that all the information provided by me is true and to the best of my
knowledge.
Place:New Delhi (MUKESH KUMAR)
Date: