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Paralegal – Licensing & Regulatory Compliance

Date Posted: July 1, 2026
Job Type: Full Time
Job Summary:
Responsibilities:
  • Prepare, submit, and track applications for state pharmaceutical manufacturing and distribution licenses across multiple US states.
  • Coordinate and maintain pharmacy and 503B outsourcing facility licenses, including initial applications, renewals, and amendments.
  • Assist with DEA registrations, modifications, and renewals, and maintain supporting documentation and records.
  • Monitor license status, key dates, and renewal deadlines; maintain an accurate licensing calendar and proactively initiate renewal processes.
  • Compile, organize, and verify required documentation (corporate, regulatory, quality, facility, ownership, etc.) for license submissions.
  • Draft and edit forms, cover letters, attestations, and responses to information requests from state boards of pharmacy, health departments, and other authorities.
  • Liaise with state and federal agencies, respond to routine inquiries, and follow up to resolve application issues or delays.
  • Maintain organized electronic and physical files for all licenses, permits, and related correspondence.
  • Coordinate with internal stakeholders (Operations, Quality, Legal, Finance, HR, Regulatory Affairs) to gather information needed for applications and renewals.
  • Track and summarize regulatory or procedural changes impacting licensing requirements and flag them to management.
  • Support internal and external audits/inspections by providing accurate and up‑to‑date licensing documentation.
  • Prepare routine licensing status reports and metrics for management.
Qualifications:
  • Strong attention to detail and accuracy in handling forms, dates, and documentation.
  • Excellent written and verbal communication skills for interacting with agencies and internal teams.
  • Strong organizational and time‑management skills, with the ability to manage multiple applications and deadlines concurrently.
  • Proficiency with Microsoft Office (Word, Excel, Outlook) and comfort working in document management or tracking systems.
  • Ability to interpret instructions, application guides, and regulatory requirements and translate them into clear tasks.
  • Professionalism, discretion, and ability to handle sensitive company and regulatory information.
Benefits:
  • 401(k)
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance
Education:
  • Bachelor’s degree preferred, ideally in Paralegal Studies, Legal Studies, Healthcare Administration, Regulatory Affairs, or a related field.
  • Paralegal certificate from an accredited program strongly preferred (or equivalent relevant experience in a paralegal/compliance role).
Experience:
  • Minimum 2–3 years of experience as a Paralegal, Licensing Specialist, or similar role.
  • Prior experience with licensing in healthcare, pharmaceuticals, medical devices, or other highly regulated industries strongly preferred.
  • Experience interacting with state boards (e.g., Boards of Pharmacy) or similar regulatory bodies is a plus.
  • Familiarity with DEA registrations or controlled substance regulatory requirements is beneficial.
Work Location: Largo, FL
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Copyright 2025 BPI Labs, Inc | All Rights Reserved