Job Details

  • Title: Regulatory Affairs Coordinator
  • Code: RCI-8471
  • Location: Thousand Oaks California (CA) 91320
  • Posted Date: 04/06/2021
  • Duration: 12 Months
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  Job Description

***Remote***

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

 

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

 

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*

Day to Day Responsibilities:        

  • Maintain Regulatory document management and tracking systems
  • Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence
  • Responsible for maintaining the on-site hard copy Regulatory archive and overseeing incoming/outgoing off-site Regulatory document storage
  • Point of contact between Regulatory Representatives/CMC and publishing teams
  • Manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions
  • Ensuring Regulatory compliance with SOPs and Regulatory authorities
  • Provide support to RDA team members and other functional areas, including vendors
  • Collaboration with external partners/outsourced CROs
  • Manage 1572 forms for FDA submission