Research and Development Group Lead

Working Area:Research & Development of Transdermal Patch (TDP) dosage form.Providestrategic leadershipfor R&D activities related totransdermal patches and oral thin filmsin compliance withcGMP and global regulatory requirements . Define and executeproduct development strategy , includingplatform selection, lifecycle management, and pipeline planning . Overseeformulation development, process optimization, scale-up, and technology transferto manufacturing. Ensure implementation ofQbD, risk assessment, and design control principlesthroughout product development. Approve and reviewdevelopment reports, protocols, and technical documentationforCTD/ANDA submissions . Guide and supportanalytical method development, validation, IVRT/IVPT, stability studies, and extractables & leachableprograms. Ensure compliance withdata integrity, documentation practices, and regulatory expectations . Lead responses toregulatory queries, deficiency letters, and audit observationsrelated to R&D. Drivecross-functional collaborationwith QA, Manufacturing, Regulatory Affairs, Supply Chain, and Engineering. Evaluate and qualifyraw materials, suppliers, and alternate sourcesto ensure robustness and continuity. ManageR&D budgets, timelines, resources, and KPIsto ensure on-time project delivery. Lead, mentor, and developR&D scientists, managers, and technical teams . Promoteinnovation, continuous improvement, and cost optimizationinitiatives. Supportpost-approval changes, product troubleshooting, and lifecycle enhancements . Ensure alignment withEHS requirements , solvent management, and sustainability initiatives.

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