Candidate will be working remotely during COVID then required to work on site, PST.
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:
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 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
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 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"