Executive/Sr.Executive RA-API

Job Description

Registration / Submission of Drug Master Files (DMFs) for APIs with different agencies such as USFDA, EDQM/CEP, EDMF with European Authorities, WHO (including Prequalification), Korea, Brazil, Australia, LATAM, Other Emerging markets Responsible to compilation of DMFs, Review of DMFs and ensure that the DMFs complies with the ICH / USFDA / WHO / European and other applicable regulatory guidelines Responsible for receiving and responding to regulatory queries with respect to DMFs Life cycle management of DMFs -Annual Reports, Change Updates Track updates to Regulatory guidelines, Pharmacopeias and other applicable documents and guidelines and inform management and the team regularly. Responsible for handling queries regarding registration, DMFs during site audits. Responsible to review all product related documentation that goes into the DMF and / or supports the DMFs