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Assistant Manager, Regulatory Affairs
Hcfa · Ahmedabad City, Gujarat, India
About The 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.
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