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 Ensure that all regulatory requirements for successful registration are addressed during development and validation – Specifications, Impurity profiles, Different regulatory requirements wrt impurities, starting materials, analytical and process validations. Responsible for reviewing and updating regulatory impact of Quality Management System events Communication and coordination with regulatory agencies for audits / audit responses / audit follow ups and any other follow ups Responsible for compilation of Open DMFs / Technical Packages for customers and other agencies Responsible to provide technical support to Business, Supply Chain regarding regulatory queries and responses from customers, suppliers and other agencies. Support QA function for product license requirements, different requirements with state and central agencies (CDSCO) -Written confirmation, Form 44 NOCs for new products etc