Felix Pharmaceuticals

Primary Job Responsibilities:- CMC review and submission of drug products to different territories by complying necessary regulatory requirement of regulatory authorities such as US, EU, Canada etc.) - To ensure that CMC submission are error free, accurate and do comply as per Agency's guidelines, requirements and internal procedure and checkpoints.- To coach and train a small group on submission requirement and ensure they completely understand the process and requirements. Detailed Job Description- Review of CMC documents (PDR, Dissolution discriminatory report, Split study report, BMRs/BPRs, PV Protocols/Reports, hold time protocol/report, Specifications, MoA, Method validation protocols/reports, Stability protocol/data etc.) to ensure that documents do conform with regulatory guidelines.- Reviewing and finalizing the registration dossiers (CMC Part) independently as per the agency requirements for submission to regulatory authority.- Responding queries raised by Regulatory Agencies to facilitate registration approval. - Coordination with various departments like Formulation & Development, Analytical Development, Quality Control & Quality Assurance, Production and Stability departments based at R&D, Felix Plant, CRO & CMO site for facilitating the development of Products. - Assessment of change controls related to product and process development to ascertain regulatory filing strategy and data requirement to facilitate registration approval.Skills Required- Must have: Sound knowledge of regulatory guidelines applicable for registration of dossier in different territories and - Add on: Understanding of life cycle management requirements of various regulatory agencies- Experience of handling the Drug Product Registration/Submission activities with USFDA, EU and Health Canada authorities etc.- Good understanding about the criticality involved in Development and Registration of drug products with respect to business and compliance perspective (ref:iimjobs.com)