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Regulatory Affair Executive Resume Sample, Experience : 2 years

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Name of the Candidate:[Private]
Name of the Post Applied:Regulatory Affair Executive
Job related skills / software:Involved in co-ordination with Plant, R&D and QA-QC Department for preparation and receiving of Documents, Prepared dossier for different dosage forms such as tablet, capsule, cream, gel, and expectorants, Involved in setting up specifications for different dosage forms, Involved in preparation of documents.
Category:Medical
Sub Category:Drug Regulatory Affairs Executive
Years of Experience:2 years
State:Gujarat
Gender:Male
Salary Expected per Month(Rs):Negotiable
Highest Qualification attained:B.Pharm. : Bachelor of Pharmacy
Major / Specialization:Pharmacy
Email Id:[Private]
 
Are you looking for job now?:No
Can the recruiter contact you?:No
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OBJECTIVE  :
To be associated with an organization, that provides career development opportunities so that I may contribute in its progress through the best of my knowledge and skills.

AREA OF INTEREST :
 Regulatory affair

PRESENT JOB RESPONSIBILIES :
 Involved in co-ordination with Plant, R&D and QA-QC Department for preparation and receiving of Documents.
 Prepared dossier for different dosage forms such as tablet, capsule, cream, gel, and expectorants
 Involved in setting up specifications for different dosage forms.
 Involved in preparation of documents.
 Prepared dossier as per CTD format.
 Involved in Documentation of Dossier.
 Responding to queries
 Preparing Dossier as per different country requirements and format.
 Responding to queries asked by Regulatory Agency.
 Renewals of dossiers as per regulatory requirement.
 Coordination with Production, Formulation and Quality Assurance departments for timely Regulatory submission.

EDUCATION DETAILS :
QUALIFICATION BOARD/ UNIVERSITY YEAR OF PASSING PERCENTAGE OBTAINED
B.Pharm GU 2011 68.75%
H.S.C G.S.E.B 2006 65.78%
S.S.C G.S.E.B 2004 78.62%

WORK EXPERIENCE :
1) 8 month experience in Regulatory affair in west-coast pharmaceutical at gota after B-pharm during APRIL-2011 TO DEC-2011.

2) Present  : Since JAN 2012 to till date.
Designation  : Regulatory assistant
Company  : Mediwin Pharmaceuticals
Company Profile : Mediwin Pharmaceutical is a WHO-GMP certified company offering wide range of Products in Domestic and International Markets.

EXTRA CURRICULAR ACTIVITIES :
 I completed course of computer in Shiv Computer Education 0n march 2007.
 Seminar on Scope & Potential after pharmacy by I.P.E.R.
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institute on 8th Oct, 09.
 Attending IPC held in Nirma University on 11th, 12th, 13th Dec-2009.

COMPUTER PROFICIENCY :
 Completed MS-Office, easily operate other software programme
 Basic internet knowledge

PERSONAL DETAIL :
Marital Status  : Unmarried
Languages Known  : English, Hindi, Gujarati
Hobbies  : playing, reading, watching TV

KEY SKILLS :
 Knowledge of Scientific literature
 Work effectively with diverse group of people
 Ambitious, hardworking and committed to excellence.
 Critical thinking, decision-making and problem solving skills
 Good communication skills

DECLARATION :
I hereby declare that, the above given information are true to best of my knowledge and belief.

DATE  :
PLACE  :

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