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Regulatory Affairs Senior Associate

Thousand Oaks, CA

Top 3 Must Have Skill Sets:
    
• Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
• Independent time management and prioritization skills
• Critical thinking skills
*Veeva experience preferred



Description:

***Remote***
***Regulatory ops/ regulatory affairs preferred***

Job Details: All, or a subset of the following:
Quality:
• Monitoring data quality/health, including collaboration with other internal functions to maintain planned submission and approval dates

Integrations:
• Updating the Regulatory Submissions and Document Information Management System (RSDIMS)

Analytics:
• Metrics compilation and analysis
• Liaison with internal customers to improve efficiencies within RDA and other functional areas

Manages requests within the Regulatory Intake System to comply with data management of a GMP system.

Basic Qualifications:
Bachelors degree and 2 YOE preferred

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

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