About company  - Mid size Indian pharma company with multiple manufcaturing sites

Key Responsibilities:

• Define and execute R&D strategy aligned with business, portfolio, and regulatory goals.
• Lead Process R&D and Analytical R&D functions, ensuring timely development, scale-up, and tech transfer.
• Oversee development of robust, safe, and economical API processes and control strategies.
• Ensure compliance with ICH, cGMP, EHS, and global regulatory requirements.
• Review and approve DMF/ANDA/CEP technical content and responses to regulatory queries.
• Act as primary SME during regulatory inspections, customer audits, and due diligences.
• Drive cross-functional collaboration with Manufacturing, QA, QC, EHS, Supply Chain, and Business Development.
• Lead investigation and resolution of critical deviations, OOS/OOT, and process or analytical...