Regulatory Affairs Executive

  • Mumbai
  • Encube Ethicals

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