Opening in Regulatory Affairs (OSD / Injectable)-For US Market-Amneal Dear Candidate, We have urgent openings in the Regulatory Affairs department. Please see below details further and request to share your updated CV at kavitriy@amnealindia.com Regulatory Affairs-OSD/Topical Market Exposure (US Market Exposure is Must) Designation-Executive/Senior Executive Qualification: B. Pharm/M. Pharm Experience: 3-7 yrs Job Description: US ANDA complete life cycle handling experience, specifically the supplements and annual Reports submissions Basic Regulatory knowledge of Dosage forms incl. Solid oral (Tablet, Capsules), Liquid oral (Solution, Suspension) Basic Knowledge of, FDA guidance for Generic drugs, ICH Quality guidance especially Stability and Impurity requirements, Refuse to receive and Stability Question & Answer guidance, SUPAC guidance, supplement and Annual report related FDA guidance, Post approval CMC experience is highly desirable. Experience of handling change control as