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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