Regulatory Affairs Executive

4 weeks ago


Mumbai, India Encube Ethicals Full time

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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