Associate Director, CMC Dossier Strategy & Leadership
Core
Leads global regulatory dossier preparation for novel biologics by coordinating cross-functional teams to ensure high-quality, compliant CMC submission documents aligned with clinical/regulatory strategies.
Role type
Senior IC regulatory strategy lead (CMC)
Builds
Global regulatory submission documents for biologics
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
CMC regulatory submission authoring, cross-functional team coordination, global regulatory requirement knowledge, scientific writing (INDs/marketing applications), risk identification and mitigation, process development, matrix management, mentoring
Preferred skills
Biologics drug development experience, interdisciplinary experience, leadership in later-stage programs
Technologies
Regulatory guidance documents, submission document templates, project management tools
Responsibilities
Author and coordinate submission documentation for all phases of clinical development; Lead global cross-functional CMC teams; Develop standard processes and document templates; Interface with CMC Regulatory to ensure consistency; Mentor and supervise dossier authors; Drive first-pass approvals and anticipate regulatory questions
Seniority
Senior, hands-on IC with leadership responsibilities