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Regulatory Affairs Senior Associate

Thousand Oaks, CA
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:    

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 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"
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