Regulatory Affairs-API

Job Description

• Responsible for Regulatory filings for APIs and Intermediates and achieving registrations-DMF (US, Europe, Australia, Korea, Japan, WHO, other reg / non reg countries), CEPs. • Responsible for coordination of all Regulatory Query responses with agencies, regulatory related query responses with customers. • 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. • Life cycle management of DMFs, Registrations -Annual reports, change updations • Support during regulatory audits. • Support QA function for product license requirements, different requirements with state and central agencies (CDSCO) -Written confirmation, Form 44 NOCs for new products etc • Review of supplier documentation for regulatory requirements