Position: Regulatory CMC Consultant (Director-level)
Location: Remote-based with occasional travel to Bay Area, CA
Start Date: ASAP
Our client is in progress of initiating a new commercial manufacturing site and is currently seeking a Director-level Regulatory CMC Consultant with a strong background in CMC/Module 3 technical writing for IND & BLA submissions, pre-approval inspections (PAI’s), and cell therapy products. Someone who carries previous experience in writing and reviewing BLA CMC sections (Module 3, including sections 3.2S & 3.2P) is required.
The project will begin with being granted access to IND / regulatory filings, raw data, amendments, and overall getting acclimated with current project status and objectives. The project will then progress to writing and review of data, reviewing regulations, gathering data, and aligning with FDA regulations to guide through regulatory nuances to justify CMC plan.
Additionally, this individual will be assisting with compiling/authoring data packages, leading construction of briefing books, CMC strategy plan, PPQ strategy, facility fits, comparability, characterization, potency, and process development for CMC section. Strategy efforts will involve leading project discussions pertaining to CMC sections of regulatory submissions, contributing to strategy action plan, and managing project timelines.
MINIMUM REQUIREMENTS (must be needed to be considered for this role):
Director-level CMC Regulatory expertise
Technical Writing: CMC/Module 3 authoring
Extensive experience with regulatory filings & BLA Submissions
Cell therapy products (mandatory)
Excellent communication skills and ability to work in a highly cross-collaborative environment
Pre-Approval Inspections (PAI’s)
BONUS/Nice to have:
Familiarity with EU regulations
Degree in scientific area or Ph.D preferred (experience outweighs degree)
Regulatory CMC (Director Level) (232502) – Remote, CA