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
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.
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"