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Regulatory Affairs Research Officer Resume Sample, Experience : 3 years

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Name of the Candidate:[Private]
Name of the Post Applied:Regulatory Affairs Research Officer
Job related skills / software:Drug Master Files/ Technical Packages Preparation
Sub Category:Drug Regulatory Affairs Executive
Years of Experience:3 years
Salary Expected per Month(Rs):Negotiable
Highest Qualification attained:M.Sc. / MSC : Master of Science
Major / Specialization:Biochemistry
Email Id:[Private]
Are you looking for job now?:No
Can the recruiter contact you?:No
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Resume Format / CV Sample Template / Example / Model :


Summary :
In the field of Science, get to be recognized and to have selfidentity by dedicating utmost efforts. The field that offers an innovative and competitive environment to work in, leading to both professional and personal growth.

Experience :
Working as a Research Officer – Regulatory Affairs with Enalteclabs since 3 and half years.

Job profile :
Preparation and filing of Drug Master Files as per regulations in CTD format
Preparation of Technical Packages and Technology Transfer documents
Compiling, Review and Filing of dossiers for product registration and renewals
Responding to queries through electronic communication on submissions / filings made
Filling up the vendor questionnaires and check lists
Keeping abreast of legislation, guidelines and customer’s practices
Maintaining quality systems & managing regulatory inspections

Academic profile :
Master of Science in Biochemistry, Passed in 1st division from Andhra University in the year 2006
Bachelor of Science in Biochemistry, Passed in 1st division from Andhra University in the year 2004

Skills :
Ability to work to strict deadlines with strong negotiation and arbitration skills
IT skills, particularly in relation to using databases, and familiarity with commercial software

Packages :
MSOFFICE, Bioinformatics tools, Chemdraw, patent search and Internet concepts
Considerable understanding of both legal & scientific matters

Achievements :
Filed DMFs Type II for USFDA approval and another Planning for EU in last two years
Handled project on Bioinformatics titled “Comparative Homology Modeling studies of P19221 with 1HAG using modeler 8v1” at Bioinformatic Training and Research Centre, ProGene Biosciences, Vizag in 2006
Ranked as School People Leader of Kendriyala Vidyalaya (NAD), Vizag in 2001

Sports & Co curricular activities :
Selected for Volley Ball and KhoKho for various Regional and National levels held at Hyderabad and New Delhi in the period of 19972001.

Bagged gold (2) and silver (1) medal in the respective areas. Also won prizes in spot painting and poster making conducted by The Hindu and Andhra University respectively

Personal details :
Languages known  : English, Hindi, Telugu and Marati
Hobbies  : Philately and Interior Decoration

Declaration :
I here by declare that the abovementioned particulars are true & correct to the best of my knowledge and belief.

Date :
Place : Navi Mumbai


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