Job Description
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.
