Cadila Pharma

Job Profile: (ONLY INJECTABLE DOSAGE FORM)
a. Compilation, review and submission of registration dossiers of Injectable dosage form only in the regions for the USA.

b. Handling of regulatory queries/deficiencies of Injectable product USA.

c. Submission of Supplements/Variations  of Injectable product USA.

d. Review of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols, process validation protocol and report, media filter validation, sterility related documents etc. and initiation of Change Controls & Deviations.

e. Knowledge about current guidelines and expectations of the Agency for USA/ICH or EU.

f. Creation and Maintenance of Regulatory Database for all the submissions.

g. Establish coordination with other departments for ensuring the filings and query response within a time frame.

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