| Hyderabad Jobs |
| Banglore Jobs |
| Chennai Jobs |
| Delhi Jobs |
| Ahmedabad Jobs |
| Mumbai Jobs |
| Pune Jobs |
| Vijayawada Jobs |
| Gurgaon Jobs |
| Noida Jobs |
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| Banglore Jobs |
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| Vijayawada Jobs |
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| Job Location | Ahmedabad |
| Education | Not Mentioned |
| Salary | Rs 9 - 12 Lakh/Yr |
| Industry | Medical / Healthcare |
| Functional Area | NursingPharmacist / Medical Representative |
| EmploymentType | Full-time |
Desired Profile Dossier compilation & submissions for pharmaceutical product in Asian/ African Countries as per plan. Review of query and to ensure timely response to queries from Regulatory Agency. Filling of change variations and maintaining product life cycle changes post registration. Review of QMS documentation and evaluating its impact on product dossiers. Co-ordination with Plant QA & Regulatory Agency for GMP application. Documents review viz. Process validation, Specifications, STP, DMF, Stability reports, SMF and Clinical & Non-Clinical Data according to Country Specific requirements. Co-ordination with cross function team for Data collection for Dossier Filing. Experience 1 to 3 years. Industry Type Pharmaceutical/ Biotechnology Functional Area Regulatory Affairs-Pharma Education B.Pharm/M.Pharm Compensation Best in the industry Department Regulatory Affairs
Keyskills :
gmpvalidationevaluationqmsdmfstpeducationcompilationroductlifecycleagencycompensationregulatoryaffairsregulatorylifecycleprocessvalidationsmfdatacollectionclinicalfilling