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Job Location | Ahmedabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Sales / BD |
EmploymentType | Full-time |
To compile, review, and submit dossiers to different Regulatory Bodies (i.e. ASIAN, AFRICAN, ANVISA, LATAM, EU, USother Regulatory as well as non regulated bodies) Needs: knowledge of CTD and ACTD dossier preparation To review all documents required to submit for dossier To compile and submit dossier with all legal and technical requirements To follow up with client and marketing for current status of the dossier To follow up with F D and Production for Sample preparation To track all the details of life cycle of the dossier To response query raised by the Regulatory body on timely manner To coordinate with all concern department To support packing department for the development of artwork according to country guideline To apply all legal documents required to submit for the dossier, (i.e. COPP, Product permission, FSC, etc.,
Keyskills :
certifiedtipstrainer lifecycle samplepreparation dossierpreparation technicalrequirements professionalliability eu ctd latam anvisa artwork packing marketing regulatory preparation ServSafeInstruction IPSCerti