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Sr Associate Regulatory Affairs- Licensing -Remote (JP9724)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Sr Associate Regulatory Affairs- Licensing -Remote (JP9724)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 6 months with likely extensions
Job posting date: 1/31/2022
Note: Remote

3 Key Consulting is hiring a Sr Associate Regulatory Affairs-Remote for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • Ideal candidate will have experience in state licensure.
  • To maintain current state and federal licenses for the client Manufacturing and Distribution operations within U.S. Jurisdictions.

    Sr. Associate Regulatory Affairs - Licensing is responsible for:
  • coordinating license renewals and handling government interactions germane 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
  • Timely and accurate submission of license applications
  • Tracking and organization of documentation including maintenance and optimization of licensing database
  • EDMQ/EPIC document management, developing procedures to ensure regulatory compliance, and supporting the extended Regulatory Affairs team with preparation of regulatory filings and amendments.
  • Requesting checks and managing a corporate P-Card to cover State Licensing fees.
  • Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
  • Generating License reports as needed for Management or Business Integration activities.
  • Working with extended client Licensing Network including obtaining Corporate Officer approvals, arranging notarization as needed.
  • May interact with Licensing consultants as needed.
  • Entering license documents in the regulatory document management system.
  • Scan and file licensing documentation.

The person in this role must:
  • understand and complete State license application forms with relevant client and subsidiary information.
  • be able to work independently
  • know how and where to find needed information.
 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 client 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.
  • Clinical Export Reports
  • Distribution Reports
  • Establishment Registrations
  • APR Submissions and Post Marketing Commitments (Cognos Reports)
  • State wholesale and distributor license renewal procedures
  • Regulatory database procedures
  • Regulatory document management skills
  • General application management skills & strong computer aptitude
  • Attention to timeliness and accuracy

    Basic Qualifications
  • Bachelor’s degree OR Associate’s degree & 4 years of directly related experience OR High school diploma / GED & 6 years of directly related experience.
  • Experience with state license renewals and reporting.
  • Experience with Document Management Systems

Top Must have Skill Sets:
  • State licensure experience
  • CMC regulatory affairs or CMC quality experience
  • Experience with applications and databases

Red Flags:
Shorter than one or two years in previous roles.

Interview Process: phone screen with hiring manager then final phone interview with team.

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.

3KC Talent Acquisition Team
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