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Regulatory Affairs Senior Associate

Thousand Oaks, CA
Top 3 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:
  • Key Activities:
  • 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 Amgen 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
 
Job Summary

Candidate will be working remotely during COVID then required to work on site, PST.
  • 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 Amgen 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)
"This posting is for Contingent Worker, not an FTE"

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