Director, CMC Regulatory

Role: Lead global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for clinical-stage small molecule programs, supporting lifecycle management and submission activities. Responsibilities: develop and execute CMC strategies from IND/CTA to NDA/MAA; provide guidance on manufacturing changes, comparability, and control strategies; prepare and author CMC sections and briefing documents; oversee submissions, document quality, and compliance; support inspection readiness. Qualifications: Bachelor’s in life sciences; 10+ years in biotech/pharma regulatory affairs; strong experience with small molecules, IND/CTA, NDA/MAA processes; deep understanding of CMC development, regulatory frameworks (FDA, EMA, ICH); excellent communication and cross-functional leadership skills. Preferred: advanced degree (MS, PhD, PharmD), familiarity with other modalities. High-Value: small molecule development, global regulatory submissions, lifecycle management, cross-functional collaboration. Work setup: not specified; salary range $230K–$270K.