Regulatory Affairs Executive
4 weeks ago
Key Deliverables
Dossier review and complication of ANDAs for US Market.
Post approval for US
Document review i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review.
Hands on Electronic Operation (eCTD and SPL)
Labelling related activities
Skills and Requirements
Experience in US submission
Experience in US submission
Knowledge of the review of CMC documentation required for submission
Working capabilities preferably on PharmaReady software
Understanding labelling related guidance's
Positive Attitude and Approach. Learning Abilities
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