Executive / Sr.Executive-Regulatory Affairs
Preparation of DMF’s for following drug authorities FDA, EDQM and prepare dossier for suitability certificate (CEP) application.
Preparation of responses to deficiency letters received from drug authorities.
Handling technical queries / requests received from customers.
Handling technical queries / requests received from customers.
Preparation of DMF’S as per Common technical document format .
Should have Knowledge of US FDA guidelines, ICH (quality guidelines), CTD, European DMF guideline and EDQM certification procedure (CEP/COS guidelines)
Should have Knowledge of US FDA guidelines, ICH (quality guidelines), CTD, European DMF guideline and EDQM certification procedure (CEP/COS guidelines)
Preparation of USDMF updates, amendments and CEP renewals.
Co-ordinate for DMF related activities with various departments such as QA, QC, Production, R & D and Marketing.
Co-ordination with QA/Plant/R & D for completion of questionnaires received from customers.
Qualification: MSc. (Organic Chemistry)/MPharm./BPharm/BSc (with diploma in RA).
Experience : 2 to 4 years
Job Location: Dombivli & Tarapur
Job Code : EXE/RA/D2 (For Dombivli) & EXE/RA/TAR
(For Tarapur)
Those interested in applying to any of the positions mentioned above , Mail across your CV with relevant job code to hrd@calyxindia.com .
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