Role & responsibilities Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries. Review and submission of Response to queries raised on DMF by USFDA, and other agencies. Review and submission of Amendments and revisions of Drug Master Files. Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets. Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies. Review of OOS, BPR, process validation, and other quality assurance documents required for regulatory submissions. Markets Handled: USA, Europe, Canada, Brazil, other ROW etc. Preferred Candidate Candidate must have experience working in Regulatory Affairs in Pharma API Industry.

Role & responsibilities Experience in Synthesis and Development in API R&D. To develop cost effective, high quality and minimum environmental hazardous process considering ICH guideline. To finalize the route of synthesis after doing feasibility study of ROS to develop process for DMF filing. Lab process development and its optimization with control strategy and Lab validation experience of at least 3-5 products. Should be able to design, finalize and propose specification of KSM, Intermediates and finish API as per developed control strategy. Should have exposure for transfer the technology to pilot plant and PD Lab. Should able to prepare the documents for Process development report and technology transfer. Should be well aware of characterization like NMR, Mass, IR etc. Literature survey and have trouble shooting ability of plant and Lab scale synthesis, impurity problems.

Role & responsibilities Follow cGMP and regulatory standards to maintain product quality and efficiency. Oversee batch initiation and monitor production processes to ensure compliance with SOPs and specifications . Calibrate balances and other critical instruments, ensuring accurate measurements and documentation. Verify and review Batch Records (BR), Batch Manufacturing Records (BMR), SOPs, and validation protocols for accuracy. Work with QA, QC, and maintenance teams to ensure smooth operations and resolve issues. Prepare and maintain accurate production reports and documentation. Preferred candidate profile M.Sc. in Organic Chemistry / B.Tech Chemical Engineering. 2 to 7 years of experience in Production within the API industry. Strong understanding of GMP, documentation review, troubleshooting, and collaboration with cross-functional teams.