Senior Regulatory affairs Executive in WEST-COAST PHARMACEUTICAL WORKS LTD

Job Posted on Dec 26, 2018

Recruiter Type:Company
Address:Meldi Estate,
Near Prasang Party Plot, Opp. Sola Bhagwat, Sayona City Road, Gota,
Ahmedabad, Gujrat 382481
Contact Person:Lalit Prajapti
Required in:Formulation Unit
Job Department(s):Regulatory Affairs
Job Title:Senior Regulatory affairs Executive
Job Details:Preparation of registration dossiers in CTD/ACTD/Country specific format depending on country requirement.
• Arrangement of registration document as per country requirement.
• Check & approve registration documents prepared by assistant.
• To prepare, check & approve CTD/ACTD/Country specific dossiers as per country guideline.
• To check, verify & approve documents related to dossiers preparation which are received from QC & QA department for dossiers compilation.
• To verify artworks
• To check, verify & approve documents of nonclinical & clinical documents, SPC, PIL, Pack Insert, PSUR for dossier compilation, prepared by assistant
• To check & verify artworks of packaging materials of products for domestic and export market
• Day to day follow-up with various departments for dossier documents requirements
• Filling weekly & monthly work output reports & achievement of targets set by management
Regulatory Exposure:Not Required
Experience:3 - 5
Salary Per Annum:265000
Last Date:31/01/2019

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