Regulatory Affairs Specialist Full-time Job

Responsibilities

Preparation of CTD/ACTD & Country specific Dossiers Handling queries obtained from different regulatory agencies and customers across world. Compilation, preparation and review of Technical Package of APIs. Compliance to audits of regulatory bodies especially USFDA and EU. Generation of documents from, Production, QC and QA of newly developed products Responsible for record keeping and to ensure correctness of records pertaining to department. Knowledge of ICH Guidelines to prepare documents accordingly. Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents.