Associate Director / Director, Regulatory Affairs CMC

Role: Associate Director/Director, Regulatory Affairs CMC, leading global regulatory strategies for multiple modalities in a clinical-stage oncology biotech. Responsibilities: develop and execute CMC strategies across clinical and commercial phases; serve as CMC lead on cross-functional teams; author and review regulatory submissions (INDs, CTAs, IMPDs, filings); lead interactions with global health authorities; ensure regulatory compliance; stay updated on industry regulations; support inspections. Requirements: Bachelor's in a scientific field; 7+ years industry experience with 5+ in regulatory CMC; hands-on experience with CMC submissions for biologics, ADCs, or small molecules; proven ability to develop strategies and manage authority interactions. HighValue: biologics/ADC modalities, oncology focus, global regulatory submissions, ICH/FDA/EMA guidelines, cross-functional leadership, experience with Veeva RIM. WorkSetup: not specified.