Associate Director, US Regulatory CMC

Role: Associate Director, US Regulatory CMC, responsible for developing and executing US regulatory strategies for Bayer's pharmaceutical products. Core responsibilities include leading CMC regulatory activities, preparing IND and NDA submission materials, managing post-approval CMC changes, and serving as the primary FDA contact for CMC interactions. The role involves ensuring compliance with US regulations, aligning regulatory strategies with commercial and R&D objectives, and guiding multidisciplinary teams. Qualifications: Bachelor's in life sciences, with US FDA CMC regulatory experience; deep knowledge of drug development, FDA policies, and ICH guidance. Preferred: Graduate degree (PhD, PharmD, MS) and 4+ years of industry experience. High-value biopharma specifics: focus on pharmaceutical development, CMC submissions for INDs and NDAs, regulatory risk mitigation, and FDA interaction management. Work setup: hybrid role based in Whippany, NJ, with 2-3 days onsite weekly.