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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 Skills        
  • Foundational knowledge of the regulatory framework within drug development
  • Ability to understand and communicate scientific information
  • Strong technical/ scientific writing and presentation skills

Day to Day Responsibilities:           
  • Assist US Regulatory Lead to support regional regulatory activities (e.g. IND submissions and agency meetings)Complete regulatory forms to support agency communications
  • Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with Regional Regulatory Lead

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

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