Regulatory CMC (Director Level) (232502) – Remote, CA

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Position: Regulatory CMC Consultant (Director-level)

Location: Remote-based with occasional travel to Bay Area, CA

Start Date: ASAP

Job Description:

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

EDUCATION:

Degree in scientific area or Ph.D preferred (experience outweighs degree)

Regulatory CMC (Director Level) (232502) – Remote, CA

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
State
California

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