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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Regulatory Affairs Lead – Pharma/Combination Products in Warwick employer: BD
Waters is an exceptional employer that fosters a dynamic work culture where innovation meets collaboration. With a strong focus on employee growth, you will have access to ongoing training and development opportunities while working in a hybrid environment that promotes work-life balance. Located in the UK, this role offers the unique advantage of engaging directly with local markets, allowing you to make a tangible impact on customer engagement and sales enablement.
