About this role
• Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid, injectable & other dosage form as per the business goals.
• Working on due diligence projects for US, EU & Canada markets as per the business agreement.
• Managing pre-approval portfolio including original submission, deficiency response, final approval request & any other submissions.
• Assessment of change controls & providing necessary regulatory comments/approval.
• Knowledge of relevant regulatory guidelines & updates is must.
• Skills like, technical writing, presentation, training, effective communication/coordination is preferred.
Experience of Nitrosamine risk assessment report review will add value.