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Regulatory Affairs - Executive / Sr.Executive

By: Pharma Career | Views: 1706 | Date: 22-Dec-2010

•Documentation and filing for drug registration.•Facilitation of internal/external(regional FDA) communication for regulatory affairs.•Reviewing of existing regulatory guidelines and global regulatory trends.•Monitoring of marketing changes, regulation changes and considering the proper measures.

Summary

Experience:
4 - 5 Years
Location:
Hyderabad / Secunderabad
Education:
UG - Any Graduate - Any SpecializationPG - M.Pharma - Pharmacy
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D
Posted Date:
21 Dec

Desired Candidate Profile

•Atleast 5 Years Experience in Regulatory Affairs.

•M. Pharm

•Knowledge on local and international regulation.

•Good communication skill with internal & external organization

• Good written & spoken English skills.

• Good computer & documentation skills.

•Self-confidence to respond rapidly to issues and to take appropriate action.

•Self-motivated, energetic personality.

•Experience submission & approval for at least 10 no. of dossier like ANDA & NDA on USFDA, MHRA and other European regulatory.

Salary will be comparable to industry standards in India. Please e-mail detailed resume giving complete details of the last drawn salary and expected salary at: daewoong_pharm@yahoo.co.in

Subject Line in Mail should be “RA_Name”, failing this the CV will not be considered / downloaded at all

 

Job Description

•Documentation and filing for drug registration.

•Facilitation of internal/external(regional FDA) communication for regulatory affairs.

•Reviewing of existing regulatory guidelines and global regulatory trends.

•Monitoring of marketing changes, regulation changes and considering the proper measures.

 
Keywords: ANDA , NDA on USFDA, MHRA ,European regulatory, Regulatory affairs

Company Profile

Established in 1945, Daewoong Pharmaceutical Co., Ltd. has the largest prescription drug sales in Korea and have presence in 7 countries, we are developing product for US & Europe market
Contact Details
Company Name:
Daewoong Pharmaceutical Co. Ltd.
Website:
Not Mentioned
Executive Name:
Kota Sarita Saradhi
Address:
Not Mentioned
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