• 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 (e.g., eCTD Module 2 summaries, integrated summary documents, Investigator’s Brochure, clinical study reports)
Desired Competency
Apply best practices for effective communication and problem-solving and demonstrate a professional manner. The candidate must be a self-starter and demonstrate commitment to the task in a highly competitive growing sales environment. Ability to use MS Office Package. Fast learner with Strong, Confident communication & listening skills. Innovation, making things happen per requirement.