Associate Director, CMC Dossier Strategy and Leadership

Role: Lead global regulatory CMC dossier preparation for synthetic molecules, focusing on late-stage development and marketing submissions. Responsibilities: coordinate cross-functional teams to produce high-quality, compliant regulatory documents; author and review submission materials; ensure alignment with global regulatory requirements; develop and maintain submission processes and templates; advise on development of control strategies; facilitate team performance and mentorship. Qualifications: Bachelor's (12 years), Master's (10 years), or PhD (7 years) in a relevant scientific field with extensive CMC experience, including late-stage development; 2+ years of leadership managing technical teams; strong background in chemistry, analytical, or formulation sciences; proven scientific writing skills, with contributions to INDs or marketing applications; excellent communication and negotiation skills. High-Value: Focus on synthetic molecules, late-stage development, global regulatory submissions, interdisciplinary CMC expertise, leadership experience, and experience translating lab work into manufacturing processes.