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Regulatory Affairs Senior Associate - Licensing  (JP8062)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Regulatory Affairs Senior Associate - Licensing  (JP8062)
Location: Thousand Oaks, CA    
Employment Type: Contract
Business Unit: RA CMC Regions & Sites
Duration: 12 months with likely extensions
Job posting date: 1 September 2020
Note: Remote until COVID-19 restrictions are lifted.
 
3 Key Consulting is hiring a Regulatory Affairs Senior Associate for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Candidate will be working remotely during COVID then required to work on site, PST.

Job Summary:
Sr. Associate Regulatory Affairs is responsible for:
  • coordinating license renewals and handling government interactions germaine to U.S. Jurisdictional licensing.
  • ensuring all State Manufacturer, Wholesale and Distributor licenses are maintained in accordance with State and Federal requirements.
  • tracking and filing necessary applications.
 
Bachelor’s degree - 4 years of Regulatory experience within Pharma or Biotech. The person in this role must: Understand and complete State license application forms with relevant company and subsidiary information, be able to work independently, know how and where to find needed information.
 
Preferred: State wholesale and distributor license renewal procedures & Regulatory database procedures (huge plus)

Top Must have Skill Sets:
  • Regulatory document management skills.
  • General application management skills & strong computer aptitude.
  • Attention to timeliness, details, and accuracy
 
Day-To-Day Responsibilities:
 Timely and accurate submission of license applications including:
  • monitoring state license renewal schedules.
  • completing state license applications and renewal forms.
  • obtaining signatures from Corporate Officers.
  • liaising with licensing consultants.
  • Notarization.
  • working in Company financial systems to request checks for state licensing fees.
  • entering licensing information and filing licensing documentation into the regulatory document management system.
  • maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
  • Additional responsibilities may include supporting U.S. Regional Licensing Team with the following.
  • Distribution Reports.
  • Establishment Registrations.
 
Employee Value Proposition:
Entree into regulatory, interesting interpretation regulation, broader impact through cross functional team, cross functional global network.
 
Red Flags: short time at previous roles.
 
Interview Process:
phone screen and then team phone interviews.
  
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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