1. Tushar P. Gadge
RESUME
Objective
To seek a career in an organization, which provides an environment contributing to continuous
learning and provides exposure to new and innovative ideas, where my skills would be utilized
to the fullest potential, thereby achieving personal and professional growth.
Summary
I am Tushar Gadge (B. Pharmacy – MBA Pharmaceuticals) having more than 5 years experience
in Regulatory Affairs. I am well versed with the registration requirements of Latin America,
Africa, CIS countries, Middle East, Asian countries, South East Asian countries and requirements
of EMA.
Work Experience
CURRENT EMPLOYER:
AJANTA PHARMA LIMITED (8st
Dec 2014 to till now)
Company Profile: Manufacturer of Pharmaceutical Products.
Position: Team Leader
Job Profile:
- Preparation of Technical Dossiers in CTD, African-CTD, A-CTD & Non-CTD format for CIS
countries, Africa, Asia, Latin America & ROW countries.
- To check & review dossier prepared by Team
- Assure completeness and overall content of the submissions
- To check data received from QA/QC/RND
- To handle queries raised by regulatory authority
- Registration, Re-registration & to take approvals periodically
- Data review for master dossiers
- Master dossier uploads in ERP system
- Master dossier publishing
- Master dossier extraction from master ERP
LAST EMPLOYER:
BLISS GVS PHARMA LIMITED (1st
Aug 2012 to 7th
Dec 2014)
Company Profile: Manufacturer of Pharmaceutical Products.
Position: Team Leader
Job Profile:
- Preparation of Technical Dossiers in CTD, EU-CTD, African-CTD, A-CTD & Non-CTD format for
Europe, CIS countries, Africa, Asia, Latin America & ROW countries.
- To check & review dossier prepared by Team
Tushar P. Gadge,
Sumati Niwas, Tirandaz Village, IIT Main Gate, Powai, Mumbai-400076
Eamil- tushargadge@rediffmail.com; tushargadage@gmail.com
Contact Numbers:- 8424059226/9096832196

2. Tushar P. Gadge
- Assure completeness and overall content of the submissions.
- To check data received from QA/QC/RND
- To handle queries raised by regulatory authority.
- Registration, Re-registration & to take approvals periodically.
- To provide the updated information and technical documents in timely manner and try to avoid
the delay in getting of approvals.
- To arrange & provide documents for various tenders.
- To co-ordinate with various departments
PREVIOUS EMPLOYER:
CIPLA LIMITED (March 2010 to 1st
Aug. 2012)
Company Profile: Manufacturer of Pharmaceutical Products.
Position: PRC- Regulatory Affairs
Job Profile:
- Preparation of Technical Dossiers in CTD & Non-CTD format for Central America & South
America.
- To arrange the all requirements for registration & re-registration as per regulatory requirements
& to assure completeness and overall content of the submissions
- Registration, Re-registration & to take approvals periodically
- Site transfer
- Multiple site registration
- To Providing the updated information and technical documents in timely manner and try to
avoid the delay in getting of approvals
- To co-ordinate with various departments
- To handle queries raised by parties & authority
- To arrange & provide documents for various tenders
- To check & approve Change Controls Form for Finished Product, Drug Substance & inactive
agents
- To arrange data from different locations
- To check orders, CMCL, SPMS, Artworks as per registration documents
- To Apply the Certificates of Pharmaceutical Products, Free Sale Certificates, Export Certificates,
Export Certificates / Free Sale Certificates, Local license copy, Export license copy as per
registration requirements
- To provide regulatory support for various departments, projects, and teams
Key Skills
- Knowledge of EMEA submission processes & dossier compilation
Tushar P. Gadge,
Sumati Niwas, Tirandaz Village, IIT Main Gate, Powai, Mumbai-400076
Eamil- tushargadge@rediffmail.com; tushargadage@gmail.com
Contact Numbers:- 8424059226/9096832196

3. Tushar P. Gadge
- Knowledge of Types of Variations
- Knowledge of preparation of dossier in all formats ICH-CTD, EU-CTD, A-CTD, and Non-CTD
- Handling queries regarding product registration
- Data review - for Quality Modules
- To check artworks for packing materials
- To check SPMS
- To fill & check order copies & order documents against registered documents
Additional Skills
- Good communication skill
- Quick learner
- High motivation for self-training on regulatory related frame
- Ability to create and maintain strong and trustful relationship with corporate groups
Achievements
1. Second prize at National Level Poster Presentation organized at MIP College Pune on NDDS
Presentation
- R-DNA Technology (Biotechnology / Microbiology)
- Packing Materials for Parenteral Products & Packing Materials specification (Pharmaceutics)
- Probiotic & Prebiotic (Pharmaceutics)
- Pharmacokinetic & Pharmacodynamics (Pharmacology)
- ADR (Pharmacology)
- Ophthalmic Formulations (Pharmaceutics)
- Drugs Interactions (Pharmacology)
- Small Volume & Large Volume parenteral Preparations (Pharmaceutics)
Academic Qualifications
EXAMINATION UNIVERSITY YEAR
MARKS
(%)
Tushar P. Gadge,
Sumati Niwas, Tirandaz Village, IIT Main Gate, Powai, Mumbai-400076
Eamil- tushargadge@rediffmail.com; tushargadage@gmail.com
Contact Numbers:- 8424059226/9096832196

4. Tushar P. Gadge
MBA Pharmaceuticals
Ulyanovsk Russian State
University
2012-2013 75.00
B. Pharm. Pune University. May 2009 65.08
H. S. C Divisional Board, Maharashtra March 2005 54.16
S. S. C Divisional Board, Maharashtra March 2003 70.66
Basic Knowledge of Windows XP, Microsoft Office 2003, 2007, 2010, Windows 7, Windows 8
Personal Details
Father Name : Mr. Patilbuwa K. Gadge.
Mother Name : Mrs. Suman P. Gadge
Date of Birth : 8th
Sep. 1987
Nationality : Indian
Marital Status : Married
Languages Know : English, Marathi and Hindi.
Tushar P. Gadge
Date: 02-05-2015
Place: Powai-Mumbai
Tushar P. Gadge,
Sumati Niwas, Tirandaz Village, IIT Main Gate, Powai, Mumbai-400076
Eamil- tushargadge@rediffmail.com; tushargadage@gmail.com
Contact Numbers:- 8424059226/9096832196