Wearehiring at Cadila Pharmaceuticals Ltd.
Job Role: Regulatory Affairs (US Market)
Job Location: Dholka, Ahmedabad, Gujarat
Experience require: Minimum 6 Years
Key Deliverables of the Role:
Compilation, review and submission of registration dossiers in the regions of US.
Handling of regulatory queries/deficiencies.
Post approval activities: Review of Annual Reports, post-approval supplements (CBE-0, CBE-30, PAS) submission.
eCTD software handling for ANDA/IND submission, query response and post approval submission.
Review and approval of functional documents such as Specifications/Test Procedures/Product Development Reports/Stability Protocols/ process validation protocols/Process validation reports Batch manufacturing records, Batch Packaging records, Formula clearance etc.
Review of Analytical method validation / verification / transfer reports.
Review of DMF and its notifications.
Review and approval of Change Controls & Deviations.
Creation and Maintenance of Regulatory Database for all the submissions.
Tracking of Regulatory Guidance Documents at the respective websites.
Imparting training across the team on new guidance documents.
Interested Candidate can share your CV
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