Job Title

Working Area: Research & Development of Transdermal Patch (TDP) dosage form. Provide strategic leadership for R&D activities related to transdermal patches and oral thin films in compliance with cGMP and global regulatory requirements . Define and execute product development strategy , including platform selection, lifecycle management, and pipeline planning . Oversee formulation development, process optimization, scale-up, and technology transfer to manufacturing. Ensure implementation of QbD, risk assessment, and design control principles throughout product development. Approve and review development reports, protocols, and technical documentation for CTD/ANDA submissions . Guide and support analytical method development, validation, IVRT/IVPT, stability studies, and extractables & leachable programs. Ensure compliance with data integrity, documentation practices, and regulatory expectations . Lead responses to regulatory queries, deficiency letters, and audit observations related to R&D. Drive cross-functional collaboration with QA, Manufacturing, Regulatory Affairs, Supply Chain, and Engineering. Evaluate and qualify raw materials, suppliers, and alternate sources to ensure robustness and continuity. Manage R&D budgets, timelines, resources, and KPIs to ensure on-time project delivery. Lead, mentor, and develop R&D scientists, managers, and technical teams . Promote innovation, continuous improvement, and cost optimization initiatives. Support post-approval changes, product troubleshooting, and lifecycle enhancements . Ensure alignment with EHS requirements , solvent management, and sustainability initiatives.