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Regulatory Affairs Senior Associate (JP8471)

Thousand Oaks, CA
Job Title: Regulatory Affairs Senior Associate (JP8471)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 4.6.21
Note: Remote
 
3 Key Consulting is hiring a Regulatory Affairs Senior Associate for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
***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:
    Bachelor’s degree and 2 YOE preferred.

Top 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:
All, or a subset of the following:
  • 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.
 
 
Employee Value Proposition:
The person in this role will gain experience in veeva and work in the document management and tracking system.
 
Interview Process:

Interviews on WebEx or Skype panel interview (45 minutes)
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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