Allucent
Biopharmaceutical
Sr.Director,CMC
“Sr. Director, CMC at Allucent. Skills: CMC strategy, Regulatory excellence, Product development plans. Lead CMC strategy. Author CMC submissions”
Industry & Context.
Problem-solving
What They're Looking For.
Must Have
B. S. , R. Ph. , M. S. , Ph. D. , or equivalent degree, Advanced scientific and regulatory knowledge, Pre-approval large biologics experience, Line management experience
Nice to Have
Prior CRO experience
What You'll Do.
Author CMC submissions
Review CMC submissions
Lead Health Authority communications
Ensure compliance with FDA
Ensure compliance with EMA
Ensure compliance with ICH
Prepare product development plans
Manage direct reports
Perform other related duties
How You'll Work.
Team & Collaboration
Leading teams
Communication Scope
Written communication; Verbal communication
Process & Methodology
Product development plans
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