SATHEESH S

EMAIL ID: satheeshsatz445@gmail.com

CONTACT NUMBER: 9629750216

OBJECTIVE
To work in a healthy & innovative environment extracting the best out of me, which is conducive to learn & grow as a
professional as well as personal level thereby directing my future endeavours as an asset to the organization.

EDUCATION
 M. Pharmacy- Regulatory Affairs, SRM Institute of science and Technology 88% Still pursuing
 B. Pharmacy, SRM Institute of science and Technology 71% 2018
 XII Green park Matriculation Higher Secondary School 71% 2014
 X Green park Higher Secondary School 90% 2012

SKILLS
 Good knowledge on marketing authorization procedure for European union
 Good Knowledge on ANDS submission in Canada
 Good knowledge on Hatch Waxman Act and Paragraph four certification
 Good knowledge on US-ANDA Filing procedure as per CTD/eCTD
 Good knowledge on ICH, NDA, ANDA preparation and submission to India, US & EU markets
 Preparation of Common Technical Document (CTD) as per regulatory requirement
 Good knowledge on module 3- Quality part and submission to key markets like EU,US,CANADA
 Good knowledge on ICH, IND, NDA ANDA, BLA, PMA and preparation and submission to US
 Marketing registration of Pharmaceuticals/ Biosimilar/ Medical device in various regulatory agencies
 Preparation and submission on DMF and ASMF as per US and EU regulations
 GMP application and certification of pharmaceutical products

ACADEMIC PROJECT
 Comparison and Similarities of generic Drug approval process in Canada and Europe

Research/ Review publications in National Journals

 Regulatory Challenges of sterile formulation development as per USFDA Perspectives

WORK EXPERIENCE
I have six months experience as project trainee in Regulatory Affairs Department in Medreich
R&D Bangalore.

SEMINARS & TRAINING

 Participated as a Delegate in the International Conference on Perspectives in Chemo metrics “ICOPIC-
2015” which was held between 10-th to 12-th February, 2015.
 Participated as a Delegate in 23-rd ISCB International Conference (ISCB-2017)”Interface of Chemical
Biology in Drug Research” which was held between 8-th to 10-th February,2017.

 Participated as a delegate in National workshop on CGMP, Compliance and Data Integrity organised by
GMP unit Manipal college of Pharmaceutical sciences 21-22 September 2018.
 Participated as a delicate in two day National Conference in Regulatory challenges in pharmacovigilance
and QBD