Regulatory Affairs Lead – Pharma/Combination Products

BD is seeking a Regulatory Affairs professional to manage regulatory activities for combination devices and pharmaceuticals. You will lead NDA/ANDA/PAS/CBE submissions, interact with FDA CDER, and drive regulatory strategies across R&D, Quality, Manufacturing and Commercial teams.

The role requires 5+ years’ experience in regulatory affairs for pharma/combination products, strong knowledge of US and global regulations, and ability to manage complex projects independently.

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