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Thursday, April 22, 2010

Drug Regulatory Affairs - Officer/Asstt. Manager

DesignationDrug Regulatory Affairs - Officer/Asstt. Manager
Job Description Preparation, Review and submission of Technical documents/Dossiers(CTD/eCTD) related to Regulatory affairs for third  country Export of Pharmaceuticals Formulations.
Preparation and Review of SOPs.
Compilation of Validation Protocols/Reports.
Preparation,Review,Submission of Technical and other Documents/Dossiers with Drug Controller General of India/CDSCO/State FDAs for-
-Registration for import of pharmaceuticals Formulations and bulk drugs.
-Import Licenses
-Export Licenses
-Manufacturing & Marketing licenses
-WHO-GMP Certification
-No Objection Certificates etc.
Liasioning with DCGI/CDSCO/state FDA offices/Directorate General of Foreign Trade /FICCI/PHD Chamber of Commerce etc.
Desired ProfileThorough knowledge of FDA regulation of India and Third Countries ,Drugs and Cosmectics Acts and rules of India and also regulatory guidelines.
•Must be from Science / Pharmacy background with Min 2 Years of Experience in same line

• Excellent command over written and verbal English communication.

• Must be Proficient in Computer skills and business communication

• Should be self motivated and result oriented

• Should be initiator , keen learner , proactive and good analytical skills

• Should have pleasing and presentable personality.

• Candidate from South Delhi, Central Delhi and Faridabad will be preferred more.

 
Experience3 - 7 Years
Industry TypePharma/ Biotech/Clinical Research
RoleRegulatory Affairs Mgr
Functional AreaHealthcare, Medical, R&D
EducationUG - B.Pharma - Pharmacy,B.Sc - Any Specialization
PG - M.Pharma - Pharmacy
Compensation:Rupees 3,00,000 - 4,50,000
LocationDelhi/NCR
KeywordsDRA, Regulatory, Documentation, Regulatory Affairs, Sr. Regulatory Executive, Registration,Import Licensing,Export Licensing,DCGI,CDSCO,FICCI.
ContactMs. Sujata 
Telephone91-11-40651100
Websitehttp://:unitedbiotechindia.com

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