Regulatory experience in regulated markets,knowledge of various country requirements,ICH.
Experience in sterile formulation filings
Designation | Executive/Sr Executive-Regulatory Affairs | ||||
Job Description | 1.preparation of registration dossiers for semi regulated and regulated markets. 2.Compilation and review of plant and R&D documents 3.Response to letters from various health authorities 4.Checking/reviewing of documents as per regulatory requirements 5.guide site for regulatory filing documentation 6.maintenance of lists/documents/records 7.co-ordinate with QA/production | ||||
Desired Profile | Regulatory experience in regulated markets,knowledge of various country requirements,ICH. Experience in sterile formulation filings | ||||
Experience | 3 - 4 Years | ||||
Industry Type | Pharma/ Biotech/Clinical Research | ||||
Role | Regulatory Affairs Mgr | ||||
Functional Area | Healthcare, Medical, R&D | ||||
Education | UG - B.Pharma - Pharmacy PG - M.Pharma - Pharmacy,M.Sc - Any Specialization | ||||
Compensation: | compensation will be at par withh industry standards | ||||
Location | Mumbai | ||||
Keywords | regulatory affairs,Regulated markets,dossiers,documentation, sterile formulation | ||||
Contact | USV Limited send cv to hrd@usv.co.in | ||||
Website | http://www.usvindia.com |
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