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Associate – Regulatory Publishing (JP7368)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Associate – Regulatory Publishing (JP7368)
Location: Thousand Oaks, CA. (remote until COVID restrictions)
Employment Type:  Contract
Business Unit: GRO Publishing UK
Duration: 1+ years (with likely extensions)
Posting Date: 6/26/20
 
 
3 Key Consulting is hiring an Associate – Regulatory Publishing for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job Description:
Duties include:
  • Creation and submission of regulatory dossiers according to FDA requirements, eCTD Guidance & Specifications and agreed upon timelines.
  • Preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standards.
  • Contribution to submission strategy and timing.
  • Contribution to the filing of ex-US regional submissions.
  • Development of global training and documentation for publishing.
  • Creation and maintenance of technical manuals, training documentation and SOPs.
  • Participation in information system and software update projects as well as ongoing system validations.
  • Interaction with vendor and supplier staff.
  • Supervision of contractors in the conduct of their duties.
 
Top Must-Have Skill Sets:
  • Regulatory experience.
  • Development of global training and documentation for publishing.
 
Employee Value Proposition:
Opportunity to join a dynamic team and chance for advancement.
 
Red Flags:
Someone without bio-pharma experience.
 
Interview process:
Video Skype Panel Interview:
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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