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CMC Regulatory Affairs Sr Mgr

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:    
  • Must have direct CMC experience (RA CMC, Manufacturing, Quality Control, etc.).
  • Must be able to work independently and multi-task in a fast paced environment.
  • Experience working on biologics and small molecules, commercial and clinical is highly desired.
Day to Day Responsibilities:        
  • Successful candidate will primarily be supporting regulatory reporting of raw material and component changes as a result of COVID-related industry wide shortages. This will include evaluating data packages, developing global filing strategies and potential communication with health authorities.
Summary
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
Responsible for the strategy and execution of the site-specific aspects of the preparation of
CMC post-market supplements and facility registrations.
Interfaces with site functions to coordinate preparation of regulatory filings, identification
of issues and factors that may implicate a regulatory strategy or activity.- Coordinate site-specific change control regulatory assessments with input from the CMC Product
teams and the CMC Region representative.
Liaise with other Functions in development, operations, and commercial to ensure alignment of
global regulatory strategies, timing, execution and plans

Core Responsibilities
Change control assessments for raw materials, components, specifications, etc.
Develop regulatory strategies and author submissions related to raw material and component shortages

Years of Experience Required for Position: 5

Education & Experience (Basic)

Doctorate degree and 1+ years of directly related experience
OR
Master’s degree and 2 years of directly related experience
OR
Bachelor’s degree and 5 years of directly related experience

"This posting is for Contingent Worker, not an FTE"
 

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