Senior ExecutiveJobs Opening in Cadila Pharmaceuticals Ltd at Dholka

FEATURED JOB

Senior Executive

Cadila Pharmaceuticals Ltd

0 Years

Not disclosed

Expired

Posted: 12 Feb 26

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.