Job Description

Preparation/review and submission of new dossiers and updates for global markets. Preparation/review and submission of responses to queries from regulatory authorities/customers. Provide technical regulatory support to CRD for various activities (route of synthesis, starting material designation, specifications design, applied testing methodologies, Analytical method validations) related to new product development and other regulatory issues as they arise. Review of R&D technical packages for new product development (NPD) as well as cost/quality improvement process (CIP/QIP) for regulatory adequacy. Coordination with R&D to discuss on process and product controls, quality, patent and special studies to respond the queries from regulatory authorities/customers. Tracking of activities status to meet the timeline for new Submissions, Responses and Life cycle management of Dossiers. Preparation/review and submission of technical packages and open parts as per customer requirement. Review of technical packages for out sourced starting materials and intermediates for regulatory adequacy. Review of analytical method validations, characterization data, process validations, analytical data, specifications/test methods, BMRs, packing material details, and stability data etc. w.r.t. regulatory adequacy for dossier compilation. Review of CSO/stability protocols [EDMS] and change controls (track-wise) related to facility, manufacturing process and control of materials etc. for regulatory adequacy. Attending to on the job trainings and off the job trainings . Updating health authority new guidelines to Regulatory affairs team. Person Profile. Education Qualification: MSc / M.Pharma,/ B.Tech / M.Tech in Chemical