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Regulatory Affairs Senior Associate

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers 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 this company, its operations, or its staff.”
Top 3 Must Have Skill Sets:    
  • Strong understanding of biological and small molecule manufacturing and testing processes
  • Ability to critically think through complex changes to determine risk to product
  • Good communication and multitasking skills
Day to Day Responsibilities:    

Assessing change controls for global regulatory reportability
Assessing manufacturing deviations for CTA/MA impact
Authoring change summaries for ARMC and updating corresponding M3 sections

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

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