Associate Director, CMC Dossier Strategy and Leadership
Core
Leads global regulatory dossier preparation for novel synthetic molecules, ensuring high-quality CMC submission documents compliant with global regulations.
Role type
Senior IC regulatory affairs leader (CMC)
Builds
Global regulatory submission documents for synthetic molecules
Domain
Pharmaceutical regulatory affairs / CMC
Required skills
CMC functional experience, late-stage drug development, regulatory submission authoring, cross-functional team leadership, control strategy development, scientific writing, process improvement
Preferred skills
Interdisciplinary CMC background (chemistry, analytical, formulation), mentoring experience, industry benchmarking
Technologies
None stated
Responsibilities
Author and coordinate submission documentation for all phases of clinical development; lead global cross-functional CMC teams; develop standard processes and document templates; collaborate on control strategy development; facilitate high-performing team establishment and mentorship
Seniority
Senior, hands-on IC with leadership responsibilities